Sak Recall

[Maggie and Jeff]

We switched to hanging bags we shall see what what the labs say.

Bye bye pureflow.

[PrimeTimer]

Question:  Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.

You will need a separate dark blue top tube and best drawn pre-dialysis.  Also, you should not take vitamins or mineral supplements a couple of days before the blood draw. 

Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested.  -  http://www.spectra-labs.com/laboratories-test-menu#search

Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...

[noahvale]

*

[PrimeTimer]

Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...

You can contact Charlonda Thrower, Patient Services Director for ESRD Network 14:

Patient Services Director
Charlonda Thrower, BA, LMSW
469-916-3808
972-503-3215 Ext. 324
email: cthrower@nw14.esrd.net

Patient and renal professional concerns/grievances
Decreasing patient conflict/Involuntary patient discharge
VocRehab/Advance care planning/End of Life
Quality control audits with results to MRB

If not familiar with the ESRD Network system, read this thread recently posted by Meinuk:

http://ihatedialysis.com/forum/index.php?topic=31444.msg475263;boardseen#new

For specific info on ESRD Network 14 which covers Texas:  http://www.esrdnetwork.org/

This page gives full staff info: http://www.esrdnetwork.org/network/who-we-are/staff.asp

noahvale: Thank you very much for the info and providing the links! I will save them. Hopefully we won't have to escalate this any further...We are taking the prescription order that the Neph wrote to a lab tomorrow that is covered by our insurance so that he can have his aluminum blood level tested. By the way, I called Spectra and they DO perform the aluminum test (and just like you said, it's the test tube with a royal-blue colored top). They said all the center would have had to do, was attach the Neph's orders to the correct requisite form, draw the blood and they will test it. I also called our insurance company and THEY TOO said that the aluminum test is covered and that Spectra is in our network. Of course, we already knew they were because that is where Fresenius has been shipping the monthly labs that I draw here at home. This is why I wish Fresenius would have given us the test tube so that we could have already tested his aluminum level by now. But nope. They said THEY would have to perform the test THEMSELVES at his appt, which was TODAY. This has been brought up with them for over a month and then to find out at his appt today that they "don't do the test" because they are not covered for it (after telling him they would perform the test), really burns me up!! Anyway, my husband is too afraid to rock the boat with them so like I said, we are going to have his aluminum tested at a lab that is covered by our insurance. What an ordeal!! And now we have to wait even longer to find out what his aluminum level is. Even the insurance company was shocked that the center did not handle this for us, if that tells you anything. 

[obsidianom]

Question:  Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.

You will need a separate dark blue top tube and best drawn pre-dialysis.  Also, you should not take vitamins or mineral supplements a couple of days before the blood draw. 

Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested.  -  http://www.spectra-labs.com/laboratories-test-menu#search

Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...

Thats weird because we are at Fresenius clinic and we are testing my wifes aluminum every month. No problems at all with it. We just got our latest and it was still up at 36 . She was at 44 so it is SLOWLY dropping. 
Yesterday we got the ok to test our actual dialystate from the sak. We are testing aluminum , and all the other levels such as potasium , sodium , etc. This will tell us if the aluminum is fixed and if the saks are actually giving the exact levels of electrolytes they claim. WE drew it yesterday and should have the results in a week. This should be VERY interesting.

[PrimeTimer]

Question:  Due to the aluminum toxicity issue with Pureflow SAK's, we told my husband's Neph that we want his aluminum level tested and she said she would order it. We do his monthly labs at home and take it to the clinic (Fresenius). The clinic then sends it to Spectra. My question is, does anyone know if his aluminum level can be tested using one of the usual monthly test tube vials or does/should it involve a whole separate vial of blood to be drawn? We normally draw "pre" dialysis: Tiger tube and Lavender and the Gold "post" dialysis. We plan on calling the center tomorrow during business hours to find out but thought I'd ask if anyone on here knows. Thanks.

You will need a separate dark blue top tube and best drawn pre-dialysis.  Also, you should not take vitamins or mineral supplements a couple of days before the blood draw. 

Spectra, like most labs used by dialysis centers, send the blood elsewhere to be tested.  -  http://www.spectra-labs.com/laboratories-test-menu#search

Anyone being told by Fresenius that they no longer test for aluminum at their center because Spectra no longer performs the test? My husband's Neph didn't know that either so wrote him a "prescription" for the test and told him he will have to take it to a lab on his own to have his aluminum level tested and...to be prepared because it could cost upward of $500. Needless to say, I am quite upset about this and concerned over the fact that this was all brought up with the Neph last month and only now are they getting around to telling my husband that their center "no longer covers/performs" aluminum tests. My husband uses the NxStage cycler and altho he did not use any of the contaminated SAKS on the Recall List, he does use SAKS and now come to find out, Fresenius never even took his baseline aluminum level when he began dialysis last September, so we have no idea what his aluminum level was before using SAKS and certainly do not know now and Fresenius will not test for it. Hhmm...

Thats weird because we are at Fresenius clinic and we are testing my wifes aluminum every month. No problems at all with it. We just got our latest and it was still up at 36 . She was at 44 so it is SLOWLY dropping. 
Yesterday we got the ok to test our actual dialystate from the sak. We are testing aluminum , and all the other levels such as potasium , sodium , etc. This will tell us if the aluminum is fixed and if the saks are actually giving the exact levels of electrolytes they claim. WE drew it yesterday and should have the results in a week. This should be VERY interesting.

Yes, your test results will be VERY interesting. Hope it turns out okay. I think my husband's Neph was a bit caught off-guard this morning because when my husband brought up the aluminum test (again), she looked at the nurse and said "I thought I ordered that last month", as if to be saying "why wasn't it done, where is it??" And the nurse snapped "we don't do that test here anymore". And the same nurse then turned to my husband and asked "why do want your aluminum tested anyway?" (As if it's her business or even up to her). He then went on to explain to her that aluminum is found in many things, including the dialysate in the SAKS and that since people with kidney disease are unable to eliminate it, it can build up in their system and so their aluminum level should be monitored. At that point, the Neph kind of gave the nurse an angry look and let out a little huff and proceeded to write my husband a prescription order to have his aluminum level tested at a lab of his choosing but, added that it could be very expensive. Luckily, our insurance will cover it. The fact that the nurse said that they (the center) doesn't perform aluminum level tests ANYMORE begs the question, "when did they STOP testing for it???" Hhmm...I'd be curious to know if they stopped testing for it around the same time of the SAK recall...perhaps I am just being overly sensitive but I smell something fishy and I do not like it. My radar is going off like crazy, you could say I have a nose for these things and I'm telling you, something does not smell right. But...my husband (the patient) doesn't want us (me) rocking the boat with his center so I am going to honor his wishes. It's his body, his decision. But still, I wish I could call the center and make them explain themselves as far as telling me they would do the aluminum test and then telling my husband no. Seems they are unorganized and...unprofessional. That in itself is scary! 

[slipkid]

@ PrimeTime.

Bastards.

Here is my latest Davita story on this issue.  I have gotten statements from Medicare, and Davita is billing Medicare for the aluminum tests.  I am on a monthly basis filling a dispute with Medicare that the tests are required because of contaminated SAKs -- faulty medical equipment -- supplied by Davita.  I hope Medicare acknowledges the complaints and bounces the charges back to Davita.  A minor victory if Medicare does so in this sordid mess.

[PrimeTimer]

My husband (the patient) just reminded me that Spectra Labs is a subsidiary of Fresenius. Maybe his center no longer test patients aluminum for fear of giving the appearance of a conflict of interest because of the SAK recall/aluminum issue. Maybe they would rather an outside lab do the testing but then why wouldn't they just come out and say that instead of putting us thru this little dance of theirs today? And even then, I wonder what would explain other Fresenius centers that ARE testing patients. We like using the NxStage cycler and we like using their Pureflow/Saks...but we also would like knowing what my husband's aluminum blood level is so that it can be regularly monitored for changes, like all other labwork. You'd think that since we are already saving the center time and money by doing hemo-dialysis at home and drawing the monthly labs ourselves at home, that they'd be willing to let us test his aluminum level at home as well or...that they would do it, like they told us they would.

  Needless to say, I am very ticked off right now but even more concerned than anything. Why would a center that has been so nice, easy to deal with and thorough suddenly become unorganized and not want to perform such an important lab test? It just does not make sense. There must be a part to this story that we are missing. Problem is, I don't give up that easy. I like to dig and seek out facts, especially when I feel something is amiss. That's a little harder to do these days, especially being the carepartner of an ESRD home-hemo patient. But, like I mentioned in my prior post, we are taking the Neph's prescription order for an aluminum blood level test to a lab approved by our insurance so at least we will not have to keep begging and/or bringing it up with his center.

[obsidianom]

In the end, any blood test ordered by a physician for any reason that is medically necessary is covered by insurance. So if the idiot clinic wont do it, you can do it yourselves at the local hospital lab and and it should be ok. I order blood work all the time and its always covered for my patients as long as i have a diagnosis.
I dont think there is any conspiracy here as Fresenius has been good to us on all tests.

On the other hand I cranked at the Fresenius people recently as I wanted them to consider doing blood work for me persoanally as the care giver/dialyzer . They make money on me doing it and we pay higher electric bills and other expenses to do it at home. I just wanted them to do something for ME , not just my wife. They basically said tough Sh--T, we dont do anything for the care giver.  REAL NICE! 

[Simon Dog]

On the other hand I cranked at the Fresenius people recently as I wanted them to consider doing blood work for me persoanally as the care giver/dialyzer . They make money on me doing it and we pay higher electric bills and other expenses to do it at home. I just wanted them to do something for ME , not just my wife. They basically said tough Sh--T, we dont do anything for the care giver.  REAL NICE!

The transplant clinic sent me 8 tubes to collect from a potential donor and ship back.   Fresenius was (by policy) unable to to the sample collection, even though it was directly related to the patient's treatment.

[iolaire]

On the other hand I cranked at the Fresenius people recently as I wanted them to consider doing blood work for me persoanally as the care giver/dialyzer . They make money on me doing it and we pay higher electric bills and other expenses to do it at home. I just wanted them to do something for ME , not just my wife. They basically said tough Sh--T, we dont do anything for the care giver.  REAL NICE!

The transplant clinic sent me 8 tubes to collect from a potential donor and ship back.   Fresenius was (by policy) unable to to the sample collection, even though it was directly related to the patient's treatment.

My nephrologist's nurse (and nephrologist) could draw blood, prior to dialysis as a courtesy they drew my monthly blood for tissue matching (now quarterly).  Probably this is because they are also doing the vein work so they have to be certified for that type of thing.  Otherwise I found it hard to get the blood drawn, once in awhile I could get Quest labs to do it as part of another draw but no-one knew how to write an order to get blood drawn that I could take with me...  The hosptial's out patient lab would do it but they charged over $75 for drawing the bood - I have insurance but that just seemed outrageous and they were not close - another reference lab would do it for $35 but only took checks and didn't bill insurance...

So you might be able to ask your nephrologist if they could help if you both go in to the office for a real appointment.

[slipkid]

Davita uses its own lab in Florida for blood tests.. We have to Fed Express our samples to them.

[Simon Dog]

Davita uses its own lab in Florida for blood tests.. We have to Fed Express our samples to them.

Fresenius also uses it's own lab (Spectra).   I Fedex my samples to NJ, and I think there is another Fresenius/Specra lab on the west coast.

So you might be able to ask your nephrologist if they could help if you both go in to the office for a real appointment.

Went to the local hospital lab - the prospective donors insurance card worked wonders.

[Maggie and Jeff]

After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13
We just sent in an AAMI to test the hanging bags.

[Hemodoc]

Does anyone still have some of their PureFlow from right AFTER the recall? If so, please PM me please.

Thank you.

[Simon Dog]

After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13

Still on Pureflow - went down from 13 to 10 after a couple of months.

[Hemodoc]

After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13

Still on Pureflow - went down from 13 to 10 after a couple of months.

Do you have the routing papers to see if it is a SAK batch made by PiSA? Some folks are still reporting high levels and others are not. I wish NxStage was upfront in relating the continued risks, but they are hiding behind ill advised K/DOQI guidelines allowing up to 10 mcg/liter of aluminum in dialysate.  Fortunately for some, it appears that they are using PiSA for some of the SAKs as well.

Once again, getting some samples from the PureFlow of the completed batch for aluminum samples is something I have asked for and yet to get any responses.  What are folks fearing that won't send in this simple test? I don't get it.

[obsidianom]

After a full month using hanging bags only Maggie's Aluminum level has gone from 18 down to 13

Still on Pureflow - went down from 13 to 10 after a couple of months.

Do you have the routing papers to see if it is a SAK batch made by PiSA? Some folks are still reporting high levels and others are not. I wish NxStage was upfront in relating the continued risks, but they are hiding behind ill advised K/DOQI guidelines allowing up to 10 mcg/liter of aluminum in dialysate.  Fortunately for some, it appears that they are using PiSA for some of the SAKs as well.

Once again, getting some samples from the PureFlow of the completed batch for aluminum samples is something I have asked for and yet to get any responses.  What are folks fearing that won't send in this simple test? I don't get it.

I should have our test results on aluminum and all other chemicals in the sak this coming week. We drew off a sample the other day. My clinic was willing to do it as my wife is still at 36 aluminum. That should give us some much needed info. I will post the results.
By the way, we did test the sodium and yes my wifes sodium did rise a bit from the sak being at 140. I relayed this to Nxstage. We will see what they are willing to do. 140 is just too high. It should be 137 or 138. That is what our clinic runs in center.

[Hemodoc]

r. O, that is an incredibly important lab. It will be the first one yet reported on the current levels in the SAKs. The guidelines state that anyone with "aluminum overload" which I have seen defined in one paper as anything above a serum level of 30, should first be treated with aluminum free dialysate defined as <5 mcg/liter.

If your wife is still at a level of 36, then circumstantial evidence is that the levels are closer to 10 mcg/liter than to 5.

Thank you for getting this test done. It is time for NxStage to stop poisoning us.

Peter

[Maggie and Jeff]

Saks are 304

hanging bags are 209

[obsidianom]

Well that report at lkeast indicates I was correct in not switching from the saks to the bags. It appears Nxstage has fixed the aluminum issue. I am awaiting our own results but assume they should be good too. We can all relax now. No more hanging bags for those who switched.

[Hemodoc]

Well that report at lkeast indicates I was correct in not switching from the saks to the bags. It appears Nxstage has fixed the aluminum issue. I am awaiting our own results but assume they should be good too. We can all relax now. No more hanging bags for those who switched.

Not so fast Dr. O.

If they truly were at the level of 5 mcg/liter, why is your wife still at 36 and others over 50? Sorry to be cynical, but FMC OWNS Spectra. In addition, why are both 5 mcg/liter in this report? Why is it not 5.1 or 5.2 ect.?

My aluminum level went up on the SAKs. If it had been 11-13.5 and then down to 5, theoretically, the levels should have dropped dramatically but they didn't. If your report comes back at 5 and if I remember correctly you also are at a FMC unit, then that would be a bit strange as well.

According to the literature, if you are at a level of 5 or lower in the dialysate, the levels in the patient are quite negligible  Your wife's levels are still in a danger zone and accumulating throughout her body.

Sorry, but I am done with the PureFlow and going to stay with the bags.  The proof is in the pudding so to speak. Folks who have switched to the bags have higher Hb levels and lower Aluminum levels. Those on the PureFlow have higher aluminum levels and lower Hb. Sorry, but that speaks louder than some reported lab result from a lab owned by the largest dialysis provider in the world. something isn't adding up.

[Hemodoc]

Lastly, if the levels truly are 5 mcg/liter, and I reiterate, if, then that proves my contention that there is NO safe level for aluminum period. K/DOQI and other sources define aluminum overload as a patient with serum levels higher than 30 mcg/liter. I would dispute that since I had significant symptoms and objective Hb drops with levels 14-17 mcg/liter. However, for sake of argument, I will give them the 30 mcg/liter level. In such a case, IF the levels are truly 5 mcg/liter, then Dr. O, your wife still has aluminum overload. And no, the PureFlow is STILL not safe.

I believe you should switch to bags immediately. A level of 36 is showing that she is still having aluminum deposits throughout her body that will take years to clear. Sorry, but I strongly disagree that we can just go back to the PureFlow.

[obsidianom]

I simply dont buy the conspiracy theory. Fresenius and spectra have no reason to lie. Wy would they cover for nxstage? If anything Fresenius would rather have us on their system and not nxstage . If they could damage nxstage it would be good for their business.
WE have 7 other patients in or area on Nxstage and all but my wife have dropped back to under 10. They are using pureflow.
In the end I think my wife is an anomaly . She had the highest aluminum around here at 44 and is slowely dropping from 44 to 39  to 36 over the past 2 months. AS long as it continues to drop on pureflow we will stick with it. We check it monthly.
Now in my wifes case we could have an issue with our well water as it is very high in aluminum. It measured .238 with the norm under .01. So it is 23 plus times too high. We are now using a Britta filter for all drinking water. I hope it filters out aluminum as we cant seem to get an answer. It does filter out most metals. We just started this last month. Hopefully it should help.
If anyone knows more about the Britta system please let me know. It uses an activated carbon and ion exchange resin to filter water.  It does list copper, mercury and cadmium , chlorine and zinc  as being filtered. Since non renal patients arent harmed by aluminum it wouldnt list it anyway.

[Hemodoc]

Actually, I didn't invoke any conspiracy theory at all. I simply stated as have several others that I don't trust the independent values of a lab completely owned by FMC. Nor do I trust the labs from DaVita for the same reason. Several have noted substantially different values on labs from these two entities and when they take them though their own medical groups such as with Kaiser.

In addition, the standard of care for anyone on dialysis with "aluminum overload" defined as over 30 in the serum is "Aluminum free" dialysate defined as <5mcg/liter. In this case, at 5 mcg/liter, they are not adhering to the guidelines since it is not aluminum free. In other words, if there is a measurable amount of aluminum they have not adhered to the guidelines.

Lastly, I am frankly surprised that your unit allows you to have the PureFlow in the first place with the well water results you have shown.

In any case, I am a month and half free of the PureFlow and my energy is starting to return, my Hb is back to normal for me values and the "brain fog" I have had for the last year is rapidly clearing as well. So, if you wish to continue the PureFlow that is up to you, but I would strongly counter that NxStage has "fixed the problem" or that you can go back safely to the PureFlow. Obviously, your wife is still aluminum overloaded at the level of 36 which statistically is not much different that 44 as far as lab variation goes.

When there is another alternative to NxStage, I will gladly say goodbye to them, they have broken the trust.