Sak Recall

[PrimeTimer]

Curious to know what those of you who are no longer going to use Pureflow/SAKS anymore are going to do. Hang bags? Go back to doing in-center? Use a different home-hemo machine or modality? What about high volume dialysis? We use the NxStage Cycler and still fairly new to this. My concern is that if you want/need to do more than 25 liters of dialysate (25 liters involves hanging 4 bags on the IV pole with a 5th on the warmer), you'd have to (if I'm correct) repeatedly clamp off bags as they empty, remove them from the IV pole and then connect new bags during treatment to do a higher volume. Or is that something we are just going to have to do if we should decide to no longer use Pureflow SAKS? Yikes! 

[Hemodoc]

I have done 40 liters since 2009 hanging bags up until FMC forced me to switch to the PureFlow last year just in time for the aluminum contamination. It is not recommended because of weight and balance issues, but I have done 40 L hanging bags for over 4 years without any problems. Needless to say, you don't try and move the machine once the bags are hung since the weight of the bags is more than the weight of the machine below. But properly balanced, it works. Once again, I am told this is not recommended, but simply my choice on how to dialyze.

[obsidianom]

Curious to know what those of you who are no longer going to use Pureflow/SAKS anymore are going to do. Hang bags? Go back to doing in-center? Use a different home-hemo machine or modality? What about high volume dialysis? We use the NxStage Cycler and still fairly new to this. My concern is that if you want/need to do more than 25 liters of dialysate (25 liters involves hanging 4 bags on the IV pole with a 5th on the warmer), you'd have to (if I'm correct) repeatedly clamp off bags as they empty, remove them from the IV pole and then connect new bags during treatment to do a higher volume. Or is that something we are just going to have to do if we should decide to no longer use Pureflow SAKS? Yikes!

The other option is getting a seperate IV pole to hang extra bags .
Personally I hate the bags . Its a lot more work then pureflow. For now we are sticking with pureflow. I am interested in watching my wifes aluminum monthly for now on it. If it doesnt improve , I might consider the bags. We do 30 liters and hanging 6 bags is a pain.

[caregivertech1]

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).

[Hemodoc]

I use the FWS 209 B warmer bags with the old fashioned warmer on the side, not the top warmer. You can place up to 9 bags on that system. I do a total of 8.

[Simon Dog]

The other option is getting a seperate IV pole to hang extra bags

Been there, done that, works great.

[slipkid]

I went to hanging bags the day I was notified of the recall.  With Nxstage's silence on the SAK issue (coverup?) and the failure of my unit (Davita) to provide more information about what is going on with the manufacture of the dialysate than what I have learned on this thread, I will not go back to using the SAKs unless and until I am satisfied that aluminum and any other contaminates are below a level I find acceptable. i am using the bags on faith that aluminum is less than the 10 micrograms per liter specification that Nxstage provided to Davita in the letter I posted (now deleted from this thread).

My caregiver and I were sold on the Nxstage system by the relatively ease of using the Pure Flow, although we were not shown nor told how difficult it would be to wrangle a water filled PAK out of the Pure Flow and drag it to our trash been.  I do not normally have the strength to hang 50 ponds of dialysate, and this is left to my wife, which I regret because she already has enough to do.  In addition, we now have an enormous inventory of boxes we are forced to store.

Tomorrow, I get results of July blood tests, so we shall see what effect of using the bags has had on serum aluminum.  June tests showed a couple of points drop, which I considered to be not statistically significant.

[slipkid]

@ Hemodoc

I have read a Nxstage document, that I can not at the moment put may hands on, that use of the Pure Flow was an optional accessory to use of the Nxstage therapy system.  How did FMC force you to use the PureFlow?  I appreciate that the issue is now moot.

[Hemodoc]

@ Hemodoc

I have read a Nxstage document, that I can not at the moment put may hands on, that use of the Pure Flow was an optional accessory to use of the Nxstage therapy system.  How did FMC force you to use the PureFlow?  I appreciate that the issue is now moot.

I moved from CA with Kaiser to Idaho. Even though I THOUGHT in my interactions with them that they had already accepted me with my prior treatment of 40 liters hanging bags, they informed me that they would not accept me unless I agreed to go to the PureFlow. Also, I am now a Group Health patient and no longer a Kaiser patient. Yes, they held me to blackmail essentially. 

In the end it was a matter of shipment costs for bags that are more than shipping the PureFlow; concentrated SAKs. So, yes, they gave me little option. I had been going to a DaVita unit while here on a temporary basis each year but they told me that DaVita had dosage protocols. In the end, I probably could have stayed on Bags with DaVita 45 minutes away, but at a lower dosage. I chose to do the PureFlow at the same dosage.

Now I am back to bags, but that is for "6 months" only at this point. I will have to fight the battle again 6 months down the road. I am sick of for-profit dialysis units plain and simple.

[Speedy1wrc]

I run 30L on the solid pole with one bag on the Express warmer. It's heavy and I have to be careful moving it. It's a bit top heavy. Indeed I use the mulriline adapter which for some odd reason on our order form is listed as waste line extensions.

I am done with the Pureflow forever.

The only other option here in the US is the babyK. That is until the Baxter machine is approved and/or another technology emerges. But for now the choices are limited. I would never go back in center. Once I started seeing how many things they were doing wrong I thanked my lucky stars I am still alive. A friend who was at that same clinic wasn't as lucky. Home hemo as a modality has helped my overall health. I do mostly feel better other than the aluminum symptoms.

[slipkid]

@ Hemodoc

The only satisfaction I am getting from this situation is the costs of the bags and shipping will eat into Nxstage's profits.

@ speedy

I will likewise never go back to in-center.  We are all between a rock and a hard place.  We need the choice of other in-home dialysis modalities desperately.

[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).

This is good to know, thanks! I might inquire about getting those to keep in our inventory and especially if we end up having to forego using the Pureflow SAKS because of aluminum issues. I don't know if we have the most current model of the IV pole, the one we have came in 2 pieces, sits on a sort of small square hard plastic stand while also screwed/bolted to the back of the cycler. We have the Express Warmer that sits on-top.

My husband sees his Neph on Thursday and hopefully agrees to testing his aluminum level. If not at clinic, then when I do next month's labs at home. Once we know what his aluminum level is, I'll post it. We never got any of the "bad" SAKS but since his baseline was never taken, we definitely want to know what his level is at.

[Hemodoc]

@ Hemodoc

The only satisfaction I am getting from this situation is the costs of the bags and shipping will eat into Nxstage's profits.

@ speedy

I will likewise never go back to in-center.  We are all between a rock and a hard place.  We need the choice of other in-home dialysis modalities desperately.

Actually, FMC is eating up the costs,  not NxStage, but yes, we are in between a rock and hard place. How soon the FDA will approve the Baxter Vivia is completely unknown at this time. We can hope for soon, but the FDA is not known for worrying about us that need these new technologies.

At least it was CE Mark approved last year which is the European equivalent of the FDA.

[Speedy1wrc]

The two piece pole is the travel pole. Why it exists I am not sure. It doesn't hold as much weight as the solid pole. If I recall I was told it holds either 20 or 25 liters. I don't remember exactly. If you use 30 L at home with the solid pole you will still need 30 L traveling.

[amanda100wilson]

I can hang 25 liters on my travel pole, but you do need to make sure that they hang towards the front hangers.  I think that if you put any more on the hangers at the back, you would probably risk counter-balancing the machine and it would tip.

[caregivertech1]

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).

This is good to know, thanks! I might inquire about getting those to keep in our inventory and especially if we end up having to forego using the Pureflow SAKS because of aluminum issues. I don't know if we have the most current model of the IV pole, the one we have came in 2 pieces, sits on a sort of small square hard plastic stand while also screwed/bolted to the back of the cycler. We have the Express Warmer that sits on-top.

My husband sees his Neph on Thursday and hopefully agrees to testing his aluminum level. If not at clinic, then when I do next month's labs at home. Once we know what his aluminum level is, I'll post it. We never got any of the "bad" SAKS but since his baseline was never taken, we definitely want to know what his level is at.

Yeah, we didn't have any "bad" saks either before June 2013 after my wife's aluminum had already skyrocked to 28 on their "good" saks.

[Speedy1wrc]

There were a few of us whose aluminum rose before the recalled SAK's. The question was always, did they have more bad SAK's that we just didn't know about? However now with the latest data it appears that it is just the spec level is/waw too high to begin with. As long as they keep the same spec nothing will change for those patients who are seeing the elevated levels.

[slipkid]

Today's aluminum chem report shows Al has dropped to 16 mg/l.  This is 10 point drop from mid-May levels.  Moving in right direction.

Symptoms:  Identifiable improvement in dry, flaky skin on forearms and calves. Other symptoms indeterminate.

As speedy has said, how low will Al levels go, even with use of hanging bags?

[obsidianom]

My wifes aluminum only dropped from 40 to 39. We are still using pureflow so I am not happy. I am considering asking about using hanging bags .
This is really frustrating.

[Speedy1wrc]

Bags are a pain no question about it. But, as more and more are finding out there levels aren't dropping on the Pureflow. Without a ready alternative it's the lesser of two evils. Hopefully sooner than later another option will be available.

[Hemodoc]

My wifes aluminum only dropped from 40 to 39. We are still using pureflow so I am not happy. I am considering asking about using hanging bags .
This is really frustrating.

Dr. O,

You have no choice but to go to the bags or go to the Baby K. The SAKs are still full of aluminum. NxStage has gone down the tubes and taking us with them. This is the most unethical thing I have ever encountered in my years on dialysis.

[obsidianom]

I screwed up the numbers. My wifes aluminum dropped from 44 to 39. So we are making slow progress. that was in 3 weeks. So we will moniter every month . As long as it keeps dropping I will hang onto the pureflow. She is doing fairly well , so i dont want to rock the boat. I hate hanging bags.

[PrimeTimer]

I wonder how much aluminum is added to our city tap water. I've read that it is a requirement for city water treatment plants to put aluminum in the water as part of the water-treatment process. This made me wonder how much aluminum we drink on a daily basis. My husband and I drink tap water, we can't afford bottled water or a fancy purifier on our kitchen faucet so we drink straight from the tap. In no way am I condoning what NxStage did as far as the "bad SAK's" are concerned but, I am wondering what their reason is for having aluminum in the SAK's and if it's possibly the same reason that city treatment plants have.

Whenever I make a new "batch" for the SAK's, I test for chloramines. Obviously the PAK does a good job at removing chlorine because the SAK's always pass the test. But for the heck of it, I've taken a tester strip to our tap water and oh boy...LOTS of chlorine shows up on the tester strip. Kind of gives me a sense of relief knowing that the PAK has removed most of the chlorine from the SAK's. Anyway, made me think about this issue of aluminum and what purpose it has being in the SAK's and if it's all for the same reasons why aluminum is added to city water. Maybe NxStage can't bring the level down any further (maybe the city can't either) than they do or if they could, maybe it would mean risking some other kind of contamination.

[obsidianom]

I have the test reults done on our well water and thfinal pak treated water.  Well water was high aluminum at .238 mg/liter.  It should be under .01.
The treated Pak water was down to an excellant .008 mg /liter. The standard calls for under .01  , so the PAK did its job well. It took my high aluminum water and brought it down to excellant levels.
This brings it down to the fact thier own PAK technology works to reduce aluminum in water. They can do it.
What occurred is that Pisa uses Purac to make the lactate. They make the solution bags . Rockwell took over the saks and did not use purac. They used a company in the US that I wont name but is not Purac. (I know the name but cant name them for legal reasons). Purac is the Gold standard in lactate . They are the best. This other company is not at their level and so we all got nailed. Before Rockwell Pisa made the saks concentrate.
According to Dr. Agar oral aluminum is not an issue as the gut blocks a lot of the absorbtion. So drinking water is not the issue . It requires direct blood to dialysate contamination to get the blood levels to rise. that is what we had. 

[Hemodoc]

Dear Prime Timer,

No, it is not an issue of not being able to reach only trace levels. Purac, the original source of lactate in all NxStage products prior to the Rockwell agreement in early  2013 makes pharmaceutical grade lactate with aluminum reduced to 0.1 ppm which is 0.11 mcg/liter.

Rockwell with an alleged outside producer had VERY high levels of aluminum in the concentrate. Remember, it is diluted to a level of 11-13 mcg/liter, but is MUCH higher in the concentrated SAK before you add the water making a batch.

That is over 100 times higher aluminum levels than the Purac which remember will be diluted further by the dialysate and be lower than 0.11 mcg liter. We may be looking at a 1000 fold difference in the final product. NxStage is not listing the aluminum content in their prior solutions so that is a bit of speculation, but probably closer to the real answer. I would like to have all of the actual numbers, but I am left only with the Purac number prior to adding to the rest of the dialysate and the FDA recall letter. But I believe it is a 1000 fold difference in the two final products as logic would dictate. In the very least it is a 100 time difference in levels.

I am not aware of aluminum being an issue in any other dialysate products which should be readily removed in an RO system. Chlorine is removed by a carbon filter system but not in the RO. That is why in-center has both carbon filters and RO systems.