Sak Recall

[slipkid]

message posted to wrong thread.

[caregivertech1]

I'd like to hear comments on something I stumbled upon that would reduce aluminum levels without hanging 5 or 6 bags. We recently switched over from 25L to 30L(thanks to the suggestions on this board). To use up the 307(50L..2 treatments) inventory, I had a 5L bag on the warmer ready to go when the cycler read 25L to go. I simply hit stop, clamped the green clamps and switched dialysate line from the pureflow to the bag and hit treatment. It takes 30 seconds. So, we got 30L of treatment..the last 5 aluminum free. We did this for several weeks and our aluminum level dropped to 13 from the high teens and low 20's. When we went to sac 302 (60L...2 treatments) with no bags the aluminum went back up to 17. I'm willing to bet if I use say 2 bags of aluminum free dialysate as the final 10L of our 30L treatment, we might get to 10 mcg or better. This would be a compromise  if you're having trouble getting bags authorized. You could actually work out of your "reserve" bag inventory. I can't believe it's come to this but the switch to bags during treatment is very easy.

[caregivertech1]

Correction to above post: When the cycler indicated "5L" remaining hit stop and connect the bag.

[Hemodoc]

Correction to above post: When the cycler indicated "5L" remaining hit stop and connect the bag.

Why compromise your health by using the SAKs at all. Let's get NxStage to STOP poisoning us. I mean, for real, that is what they are doing. Unbelievable is all I can say. This NEEDS to stop immediately.

[obsidianom]

Int Urol Nephrol. 2014 Jul;46(7):1361-5. doi: 10.1007/s11255-014-0752-8. Epub 2014 Jun 18.

Aluminum transfer during dialysis: a systematic review.

Mardini J1, Lavergne V, Ghannoum M.
Author information
Abstract
PURPOSE:

Dialysis-dependent patients are particularly susceptible to the toxic effects of aluminum (Al) because of their impaired ability to eliminate it. Al contamination of dialysis fluid remains a threat in this population. The mechanism for Al diffusion across dialysis membranes is not well established. Our objective is to verify, in AL-exposed patients, the postulate that the direction of Al transfer is predicted by the concentration gradient between free diffusible plasma Al and dialysate Al.

METHODS:

A systematic review of the literature was performed. Only papers which included Al plasma concentration ([Al]p), Al dialysate concentration ([Al]d) and direction of Al transfer (positive = from dialysate to plasma, negative = from plasma to dialysate) were selected. We also included four patients from our own cohort. Assuming that [Al]p has an ultrafiltrable fraction between 17 and 23 %, cases were considered in keeping with our hypothesis if any of the following scenarios was present: negative Al transfer when [Al]d < [Al]p*23 % and positive Al transfer when [Al]d > [Al]p*17 %.

RESULTS:

The search yielded 409 articles, of which 12 were selected for review. When reviewing individual patients for analysis, 108 out of 115 (94 %) patients followed our hypothesis. By further excluding cases in which Al transfer could not be determined, only three out of 111 patients were contrary to out hypothesis.

CONCLUSION:

Comparing ultrafiltrable Al to dialysate Al permits to accurately predict the direction of Al transfer. The optimal [Al]d should be <20 % of the maximally acceptable [Al]p. In order to follow K/DOQI guidelines ([Al]p < 20 μg/L), the [Al]d should therefore not exceed 4 μg/L. At the level presently supported by K/DOQI ([Al]d < 10 μg/L), [Al]p could realistically reach 50 μg/L and potentially cause toxicity.

[Hemodoc]

Dr O, I read this article a while back and it truly bothers me as well. Why, we can produce products that are essentially aluminum free. Why then are we even setting a limit of 4? Why not go with 0.1 ppm (0.11 mcg/L) that Purac obtains in their pharmaceutical grade lactate products?

They are asking the wrong question. What level of aluminum can cause problems? It appears to me with a level of 16 and symptomatic with low Hb and diminished mental capacity, that is way TOO HIGH. Why have ANY aluminum.

Sorry, but this article is just blowing smoke from you know where and looking at the wrong answer in their question right from the beginning.

[PrimeTimer]

The NxStage Online Dosing Calculator appears to require a physician's license to be entered. People are going to need to ask their doctors to do this for them.

As for increasing dialysate per treatment for instance, to 40-50 liters, those using the Pureflow SAK's wanting to avoid aluminum will need to hang 8-10 of the Pre-Mixed Bags instead. And regardless of whether or not anyone wants to increase their dialysate, if they want to avoid aluminum and are using Pureflow SAK's, they will need to have their doctor rewrite their prescriptions so they may use Pre-Mixed Bags. As for those doing in-center, I suppose they do not have to worry about aluminum so, that would be another option for those using Pureflow SAK's wanting to avoid aluminum. Much to decide. Good luck everyone.

[obsidianom]

This is an interesting article. I cant recommend melatonin just from this article but melatonin has shown many positive effects in humans anyway. Perhaps this is another.

Food Chem Toxicol. 2014 Aug;70:84-93. doi: 10.1016/j.fct.2014.03.043. Epub 2014 Apr 12.

Effects of melatonin on aluminium-induced neurobehavioral and neurochemical changes in aging rats.

Allagui MS1, Feriani A2, Saoudi M2, Badraoui R3, Bouoni Z2, Nciri R2, Murat JC4, Elfeki A2.
Author information

Abstract

This study aimed to investigate the potential protective effects of melatonin (Mel) against aluminium-induced neurodegenerative changes in aging Wistar rats (24-28months old). Herein, aluminium chloride (AlCl3) (50mg/kg BW/day) was administered by gavage, and melatonin (Mel) was co-administered to a group of Al-treated rats by an intra-peritoneal injection at a daily dose of 10mg/kg BW for four months. The findings revealed that aluminium administration induced a significant decrease in body weight associated with marked mortality for the old group of rats, which was more pronounced in old Al-treated rats. Behavioural alterations were assessed by 'open fields', 'elevated plus maze' and 'Radial 8-arms maze' tests. The results demonstrated that Mel co-administration alleviated neurobehavioral changes in both old and old Al-treated rats. Melatonin was noted to play a good neuroprotective role, reducing lipid peroxidation (TBARs), and enhancing enzymatic (SOD, CAT and GPx) activities in the brain organs of old control and old Al-treated rats. Mel treatment also reversed the decrease of AChE activity in the brain tissues, which was confirmed by histological sections. Overall, the results showed that Mel administration can induce beneficial effects for the treatment of Al-induced neurobehavioral and neurochemical changes in the central nervous system (CNS).

[Angiepkd]

I took melatonin for sleep issues during my time on D. I was prescribed 3mg tablets taken once daily before bed. I feel like I still suffered many of the neurological symptoms of high aluminum levels.  Not sure if these were all due to aluminum, though, as many symptoms are similar to those caused by kidney failure and D.  Interesting theory.  Maybe my symptoms would have been worse without the melatonin.

[Maggie and Jeff]

I've been out of the loop for awhile.

Maggie's AL when up while using Saks this last month.

We AAMI tested 2 Sak lots and one Hanging bag lot

Both the Saks tested .005

The Hanging bags tested >.005

We are switching to hanging bags.

[Simon Dog]

I've been out of the loop for awhile.

Maggie's AL when up while using Saks this last month.

We AAMI tested 2 Sak lots and one Hanging bag lot

Both the Saks tested .005

The Hanging bags tested >.005

We are switching to hanging bags.

Is there a typo?  You are reporting the bags tested higher than the saks.

[Maggie and Jeff]

I've been out of the loop for awhile.

Maggie's AL when up while using Saks this last month.

We AAMI tested 2 Sak lots and one Hanging bag lot

Both the Saks tested .005

The Hanging bags tested >.005

We are switching to hanging bags.

Is there a typo?  You are reporting the bags tested higher than the saks.

No typo 2 SAK lots showed .005
The hanging bags showed less than (>).005

I think .005 is the lowest the AAMI test goes so the SAKs are showing they are equal to .005 and the hanging bags are showing less than the .005

[Simon Dog]

No typo 2 SAK lots showed .005
The hanging bags showed less than (>).005

Where I come from, ">" means greater than and "<" means less than.

[noahvale]

*

[Simon Dog]

No matter where anyone is from, the universal symbol for LESS THAN is "<" and GREATER THAN ">"  This might help to remember:

You mean it's not like driving on the right side of the road vs. driving on the left, or a right hand vs. left hand stereoisomer 

[Maggie and Jeff]

Ya'll are correct.   I never said I was any good at math.

<.005 for the hanging bags

I'll scan in the print out when I have time and post it

[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. 

[noahvale]

^

[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

Thanks, noahvale! ONCE AGAIN, someone on this site comes thru! Guess I will be going down to the clinic tomorrow to get the blue tube but not before I call them to ask why they didn't give it to us in the first place. It's been a few weeks since my husband's last appt when the Neph said she'd order the aluminum test and here we are, "monthly lab time" BUT....no one told us that it would be a separate tube and they also failed to mention anything about not taking vitamins/mineral supplements for a few days prior to the test. Sure wish I had asked this question sooner (and now I am going on a rant)    but you'd think that when a doctor says they are going to order a test, they WOULD ORDER THE TEST!! And the fact that this involves testing for aluminum poisoning really P---sses me off! 'nuff said. 

I may have been born at night but, I wasn't born last night! 

[Speedy1wrc]

Nothing new to add, but yes a special dark blue top. The top is aluminum free so there is no cross contamination. Since the recall I have been getting a dark blue tube every month for rhe forseeable future. Just did labs today and am anxious to see how low my levels have dropped.

[PrimeTimer]

There's actually a warmer line for 8 hanging bags. Nxstage number FWS 308......24 to a case. Also they have a stronger pole that doesn't collapse or break down. We're taking aluminum today. If not going down we'll likely go to bags (6-30L).

caregivertech1: Thanks for including the item number for the warmer line for 8 hanging bags (FWS308) in case my husband's aluminum level comes back too high and we decide to hang bags. But, in speaking with NxStage today, the new "S" cycler we are getting cannot be ran at higher ultrafiltration or volume rates using bags...only with Pureflow 400 Series SAK's. But they did say we can run at the same (slower) rates we were using on the System One Cycler using the bags. My guess, is that at a faster rate the dialysate wouldn't have the chance to get warmed up enough passing thru the warming bag and could cause patient discomfort, injury or even hyperthermia. Anyways, I pray we do not have to use bags but if my husband's aluminum level comes back too high...oh well...there goes the Pureflow machine...  Would also be quite angering! 

[caregivertech1]

Also, if you want to use the Nxstage dose calculator just put in a phone number when it asks for your medical #. It worked for me and I've been using it to actually lower our speeds.

[PrimeTimer]

Also, if you want to use the Nxstage dose calculator just put in a phone number when it asks for your medical #. It worked for me and I've been using it to actually lower our speeds.

Thanks, might give that a try.

[Maggie and Jeff]

Also, if you want to use the Nxstage dose calculator just put in a phone number when it asks for your medical #. It worked for me and I've been using it to actually lower our speeds.

Thanks, might give that a try.

Worked for me.

[caregivertech1]

FYI. wife's AL dropped to 12 from 17(was in the 20's) 2 weeks ago. Started again using one 5L bag for the final 5L So that's 25L of contaminated pureflow and 5L of "clean" dialysate. Others in our clinic are still around 20. When you think about it that last 5L cleans twice the blood  volume of the body at 350Qb and just maybe removes the AL contamination from the pureflow before it combines with protein which is a much larger molecule. All bags is the way to go but until I can get there this may be working. Thinking about 10L now...one on the warmer and one hanging. Another AL test in 2 weeks.