Sak Recall

[slipkid]

Just got a phone call from my unit that Nxstage has issued a recall on Saks.

The affected lot number (so I was told) is for SAK-307, 40179125.  Instructionss are to drain and use bags is one of the bad Saks is in the machine.

Alleged reason is high aluminum levels.

I been using the affected SAKs for two weeks.  Our latest delivery is OK.

Curiously, the unit had not heard of the oversized PAks... YET!

[Hemodoc]

Nice, my aluminum has been high for the last three months without explanation. Nice.

[slipkid]

More news on the SAK recall.

The lot number I gave yesterday is NOT the only one affected with high aluminum.

My nurse at Davita is coming to my house in an hour to take a blood sample for testing, so these folks are sufficiently shaken up to run a test.

Symptoms of aluminum toxicity are agitation, mental confusion, and muscle rigidity - convulsions.  I convulsed last night during dialysis that scared  the daylights out of my wife.

I am definitely suffering from agitation, 'cause I'm as mad as hell.

[obsidianom]

Here is the latest direct from the company. Any sak type could be involved.  The involved Lot numbers all start with 401 and 305. As far as they know , that is it. I am working on finding out more. I will post as I find out. The saks were produced last spring so they have been out there awhile.

[cdwbrooklyn]

My nurse just called me at work 1/2 hour ago to tell me to text her my SAKs lot numbers when I get home.  I know for sure that I'm using 401 and have to drain my Pure Flow tonight.  I'm glad this is my off night.  No wonder I felt confused most of the time, a little agitated, and some muscle rigidity.  DaVita is slacking up.... Praise God that they discover this problem.   

[obsidianom]

Its not all saks that begin with 401. So make sure you check the entire number .
Anyone who has been using the contaminated saks should talk to their nurse and or doctor to consider checking their aluminum levels.

[Simon Dog]

I just got an email from the RN at my clinic telling me not to use SAKS 40179162 and 40179163 (she checked the records and alerted me to the recalled SAKs that I was shipped).  Of course, I get this email the day after I use my last SAK in the recalled batch.   She also advised I need to draw a navy blue topped tube for an AL test at the next monthly labs.

[obsidianom]

I am concerned about the past 12 months since the saks were manufactured last May. WE are having NxStage go back over the past year and see if we used any of the contaminated saks. Then if we did we will draw the aluminum levels.  Isnt this fun.

[Simon Dog]

WE are having NxStage go back over the past year and see if we used any of the contaminated saks.

This sort of thing is why I keep my treatment flow sheets in an SQL database  - It makes it real easy to look this sort of thing up.

[cdwbrooklyn]

WE are having NxStage go back over the past year and see if we used any of the contaminated saks.

This sort of thing is why I keep my treatment flow sheets in an SQL database  - It makes it real easy to look this sort of thing up.

I should start doing that...this thing is crazy.  Like we don't have enough problems. 

[Bill Peckham]

These are the lot numbers of the SACs in question:


Jan 2014   40179127, 40179107,40179106,40179105, 40179093,40179034
Dec 2013  31279120, 31279118
May 2013  3057921,3057920,3057915,3057914,3057906,3057905
April 2013  3047924,3047923


Note I am not sure if these are the complete list or just the ones relevant to NKC

[slipkid]

I have gone back through my blood test results, and aluminum levels are taken yearly by Davita.

My January 2014 level for aluminum was 18 (no units given on data sheet... really scientific!!!!)

The reference range is 0-9.

So I am 100 percent above the high limit, and INFINITY above the low limit.

This may explains some of the symptoms I have been having post dialysis that I have not related to this forum.

This shoots a cannonball through the notion of the so-called "ultra-pure" dialysate that has been trumpeted by some on this board.  I asked my nurse this morning whether the FDA has been notified and she said yes.  The recall is not on the FDA's website yet, but it does show a number of recalls on Pure Flow SAks for a number of years.

My nurse also took a water sample from the Pure Flow.

I want this shit out of my system.  What is Davita going to do about it (presumably Fresenius as well) and how fast are they going to move?

NEEDLESS to say, everyone should be tested for aluminum.

[Speedy1wrc]

Your center should have an email from NxStage with the affected SAK numbers and the associated lot numbers. There are different lot numbers for different SAK numbers. I had clinic yesterday so my nurse gave menthe complete list, and it's long. Everyone should get a copy of the letter soon. You will need to verify whether you have any of the bad SAK's and that you have been informed of the problem.

This explains a lot. When I started home hemo on bags my aluminum level was normal. When I started using the Pureflow it skyrocketed. We eliminated all of the usual suspects and my nurse even called NxStage to verify it wasn't coming from the SAK's. She was assured by them that everything was normal with the SAK's.

My aluminum is very high and I have had the typical symptoms, so this concerns me. I am also curious if it actually could affect bags too. The problem is with batches of the lactate used to manufacture the product. I wonder if that same lactate was used to manufacture bags as well.

The nurse drew an aluminum on me yesterday.

[obsidianom]

I am interested in everyones symptoms. Please list your sypmtoms you believe are related to aluminum.

[slipkid]

@ Speedy1wrc

I have been concerned about the lactate in the dialysis for some time.

I had my blood levels checked before and after a session and the level was 10 mg/dL (reference range 4-16 mg/dL) at the start of the session and 56 mg/dL at the end of the session.  This is a 460 percent increase.  No one at Davita seemed concerned, but I was shocked.

I requested changing to bicarbonate dialysate, but Nxstage turned me down (so I was told by Davita).

[slipkid]

I spoke to legal counsel yesterday, and he cautioned me to revealing symptoms of alleged aluminum poisoning on an open forum.

He also recommended I hold on to any unused SAKs affected by the recall, and not turn them back to the dialysis clinic.

I wonder why?

[obsidianom]

No one seems to have posted symptoms. I am really interested in that as a doctor and spouse of patient.

[Hemodoc]

@ Speedy1wrc

I have been concerned about the lactate in the dialysis for some time.

I had my blood levels checked before and after a session and the level was 10 mg/dL (reference range 4-16 mg/dL) at the start of the session and 56 mg/dL at the end of the session.  This is a 460 percent increase.  No one at Davita seemed concerned, but I was shocked.

I requested changing to bicarbonate dialysate, but Nxstage turned me down (so I was told by Davita).

Lactate is converted to bicarb in the liver. As long as you have a healthy liver, not a big deal.

[slipkid]

@ Hemodoc

My research revealed that some lactate is converted in the brain, which makes lactate as a potential source of aluminum potentially more significant.

Nevertheless, we are entitled to a thorough investigation of the dialysate Nxstage is using, from the Pure Flow concentrate as well as to the bags.  Nothing less will satisfy me.

[Simon Dog]

@ Speedy1wrc
I requested changing to bicarbonate dialysate, but Nxstage turned me down (so I was told by Davita).

NxStage did not turn you down.   The NxStage system is lactate based; the BabyK and 2008 series Fresenius machines are bicarb based.    NxStage could inform you "we don't have a bicarb based system", however, only your clinic or Dr. could actually "turn you down". 

I spoke to legal counsel yesterday, and he cautioned me to revealing symptoms of alleged aluminum poisoning on an open forum.

He also recommended I hold on to any unused SAKs affected by the recall, and not turn them back to the dialysis clinic.

He wants to preserve your ability to file contingency fee litigation, and wants the bags preserved as evidence.   "Don't talk about the case except to your legal team" is the first thing any civil or criminal lawyer will tell the client.

[Simon Dog]

I was contacted by the RN who supports my dialyis and told lot numbers 40179162 and 40179163 were included in the recall (she only informed me of lot numbers I was on record as having received).

These are the lot numbers of the SACs in question:


Jan 2014   40179127, 40179107,40179106,40179105, 40179093,40179034
Dec 2013  31279120, 31279118
May 2013  3057921,3057920,3057915,3057914,3057906,3057905
April 2013  3047924,3047923


Note I am not sure if these are the complete list or just the ones relevant to NKC

[slipkid]

@ Simon Dog

Nxstage has a bicard-based Pure Flow concentrate, I have a copy of the FDA letter approving it use.  You'll also find with some research the SAK types and element concentrates.

Re lawyers:  My comment was rhetorical.  If patients have high aluminum levels from the dialysate there may be legal liability if damage has been caused.  Believe what you want, but I had good reasons for consulting with counsel considering the potential toxicity of aluminum poisoning.

My neph told me Nxstage turned me down for the bicarb-based Pure Flow product.

[Bill Peckham]

I think this is the complete list of the SAC lot numbers in question
>PDF Attached< must be logged in to view

[Bill Peckham]

I believe the bicarb based dialysate is for their acute operations; it is not available for their chronic operations due to the shortened (nearly nil) shelf life of bicarb based dialysate.

[slipkid]

Bill:

The bicarb-based PAKs are a two stage design which requires mixing before use.  Shelf life is not the issue.  Nxstage profits are.