Pureflow Pak don't fit

[Maggie and Jeff]

We also have had those bad days. 

Well I just got told they don't want any more of the Paks back.  Said they would send a replacement. I asked if they would send a thin one he said he hoped so.

[Maggie and Jeff]

Well,  The most recent to wide pak I called in I was told we can use or discard these paks.  I was asked to continue reporting these paks and it is my choice to discard or open the pak and remove the foam.  They will keep sending replacements or not it is my choice.

So for now I'll let them keep sending them.

[Speedy1wrc]

I'm on my last batch for this PAK so I'll use the new one that I just got to see what it's like.

[Speedy1wrc]

I chose the PAK with the newest lot number to see if it would fit. It didn't. It seemed to be the same in every respect to previous PAK's other than being a touch wider. The lot# was 41079023. I called NxStage and the rep said that they have seen 1 or 2 that have expanded and might be difficult to install. He was going to keep going, but I stopped him and told him I already knew about ALL the failures. At that point he said he'd send me out a new one, and some bags to replace what I needed to use till it came in.

[Maggie and Jeff]

I doubt the new one will fit either. 
I could post directions on how to remove the packing that makes the pak to wide. 
Basically you cut the tape open the box and get the grey foam packing out then close it back up and use as normal just don't pinch the hoses. 
I'm sure they will get it fixed eventually but I think they already have thousands of them produced like this.
I have received over 20 of them in the last 6 weeks.

They didn't want it back and said to discard the pak, right.  Or if you want to you can remove the shipping foam and use the pak. at least that's what they told me pak before last.

Ooh Yah I got another to wide pak yesterday.   

My lot #'s have been 41079xxx  the last 3 #'s have been different. Although I have got some with the exact same lot #'s

When your new pak comes in check it to see if it will fit and call it in.  You don't have to put it in the pureflow to check you can see the packing foam through the slit in the left side.  Some of them have expanded my butt every single one with foam that I've tried will not fit unless forced in.  And if you do force it in it's a real bear to get back out.

I'll keep posting if I keep getting wide paks. 

[Speedy1wrc]

You guessed correctly, the new PAK didnt fit. I measured about 5mm difference from the old PAK and the two new ones. The new ones I received actually have white foam. I will hold onto them for now.

The lot#'s I have are 40179xxx and 40379xxx. You can decode the lot # to get an idea what you have. The first digit is the year 2014. The second two are the month and the fourth and fifth and likely a product code. Cartridges are 77, SAK's and PAK's are 79. The last three are the lot. I don't know this for fact, but it seems likely. It's almost identical to how we generated s#'s for our products. The only difference was we had a letter for country of origin code in the middle and since they were s#'s we used 5 unique digits for each unit at the end.

Oh and NxStage was also supposed to send me bags to replenish my supply while waiting for the new PAK. I told them I use 30L which would be 6 bags per treatment. They sent me 4. So now they are overnighting another PAK and 6 bags and another 3 by ground.

Someone needs to walk down to the warehouse and yank the bad PAK's. Maybe they can somehow rework them. But at least they aren't sending them out and at a high cost only to fail again.

[Maggie and Jeff]

I had another one today 40379xxx.  No replacement sent out cause I will use the ones I have and there are 3 more on there way.  The guy I spoke with today is one of the higher up's great guy anyway sounds like the ones being made now are not the same as what we have been getting but they are not pulling the wide ones.  I guess it is like when a child eats dirt "This to shall pass".

You are allowed at the least a 2 week supply of hanging bags and I suggest you have that on hand during the winter this year our supplies got delayed 2 weeks and our pureflow was down and back ordered for 3 week these events overlapped.  We have a 4 week supply cause we travel a lot for 3-4 days at a time.  Customer service says we have a warehouse.  I say it's just 2 skids worth.

[Speedy1wrc]

The one I got yesterday is too wide again. Lot# 4037xxxx The tech I spoke to today said they are aware a "few" bad PAK's did get shipped out. I had to inform him I got 3 this week and you got over 20. I think he was truly surprised. He also told me they aren't shipping any more bad ones out. So I had to again inform him they still are, since I just got one yesterday. Clueless, absolutely clueless. He was encouraging though when he told me he "hoped" the next one I get will be good. OMG!

[Speedy1wrc]

NxStage is brilliant.

So for the last two weeks they have been sending me defective PAK's, and then bag's to tideme over. Every time I tell them I use 30L per treatment and they send me 20L. Then the next day I get 2 or 3 more cases. Sigh. So Saturday I was expecting a PAK, and not surprisingly....nothing. I figured it would be here this morning then, and nothing. So I call and all I got was, the person must have forgotten it was Friday and it would be here today. I tell them it wasn't here today and no response other than sorry. Then I was told the bags were coming ground and I say when am I supposed to do a treatment, a week from now and....sorry, but nothing more. Amazing.

So I am reviewing my inventory to see how many bags I have to get me through and I notice they are all wet. I open 3 boxes and they're leaking. Wonderful! So I painfully call back and try to explain why I need more bags and the person in ordering/customer support just isn't getting it. Finally she says she will and them out. I ask for tomorrow right? And she says no, ground of course, so again I have to explain I NEED them because I have no good PAK's. So then she finally says, so I should send them out overnight?

But to take the cake I ask her what they are doing about all the bad PAK's and she had no idea what I was talking about. There is some serious lack of communication going on there.

[Maggie and Jeff]

 

I suspect this is going on all over the county.  PITA is what it is for those who don't just fix their own paks and we shouldn't have to.

I got another one this weekend it probably came Friday but I've been out of town.

I could post pictures on how to fix your pak if you want just say so.

I plain on fixing all the ones I have after the next 2 come tomorrow.  Probably take me and hour or so to do all 10 of them. 

Let me Know if I should take pictures.  I wouldn't mind and may do it anyway. 

[Maggie and Jeff]

So the order came today 2 more wide paks.  I called and reported all 3 I tried to tell him I'll fix and use the 10 I already have but he said he has an email saying to ship replacements.  3 more on the way  

They must be trying to purge the system.

    Go NxStage  You Can Do it.  

 

[obsidianom]

I will break my silence for this.
The problem occurred when they tried this new foam to protect the PAKs in shipping from damage. Unfortunatly the foam manufacturer gave them bad info on how the foam would expand in shipping. It expanded more than they expected causing the extra wide PAKS. I talked directly to my contact way up in the company whom I wont out. . I got the truth about 10 days ago.
I was told to try and use the PAKs if possible. I was told it is hard to damage them and it is ok to force them or play with them to get them to fit. it wont damage the inner workings. Eventually the defective ones will be gone. So try to work through this until it smooths out.

[Hemodoc]

I will break my silence for this.
The problem occurred when they tried this new foam to protect the PAKs in shipping from damage. Unfortunatly the foam manufacturer gave them bad info on how the foam would expand in shipping. It expanded more than they expected causing the extra wide PAKS. I talked directly to my contact way up in the company whom I wont out. . I got the truth about 10 days ago.
I was told to try and use the PAKs if possible. I was told it is hard to damage them and it is ok to force them or play with them to get them to fit. it wont damage the inner workings. Eventually the defective ones will be gone. So try to work through this until it smooths out.

That is completely unprofessional to say the least. NxStage should recall all of these if nothing more from a business point of view in the extra costs of shipping. Unreal that a top level NxStage person would make that comment. They are now a for-profit dialysis company. Many of their latest actions are granting me no peace on how they will act as they continue to grow.

[Speedy1wrc]

I see several issues.

One is that they screwed up and made bad PAK's. OK, it happens. Should it, no. I guess if it were my company and I was changing something I would want to make sure and QC the change before releasing product. But that's the engineer in me. Measure twice, cut once.

Two is that there has been no communication to anyone on this. My nurse hasn't heard a word. That is unacceptable. Not everyone is resourceful to modify a PAK. It could lead to critical situations where a good replacement PAK is unavailable and a patient needing treatment. Sending out bad PAK after bad PAK is also not fiscally responsible. I can't imagine what they have spent just on me with 6 PAK's shipping overnight and all the cases of bags too.

But he latest lack of communication got me. Where one hand doesn't know what the other is doing. There is no excuse that half of their company doesn't know what the heck is going on.

[Hemodoc]

I see several issues.

One is that they screwed up and made bad PAK's. OK, it happens. Should it, no. I guess if it were my company and I was changing something I would want to make sure and QC the change before releasing product. But that's the engineer in me. Measure twice, cut once.

Two is that there has been no communication to anyone on this. My nurse hasn't heard a word. That is unacceptable. Not everyone is resourceful to modify a PAK. It could lead to critical situations where a good replacement PAK is unavailable and a patient needing treatment. Sending out bad PAK after bad PAK is also not fiscally responsible. I can't imagine what they have spent just on me with 6 PAK's shipping overnight and all the cases of bags too.

But he latest lack of communication got me. Where one hand doesn't know what the other is doing. There is no excuse that half of their company doesn't know what the heck is going on.

Well stated.

[Maggie and Jeff]

First here you can see the foam that makes the pak to wide.



Here is the pak



I peeled the tape back 6 black pieces and the top handle.





Opening the back flap





Flipped the pack over to peel back the rest of the tape.









When opening I found it helpful to press on the front near the label so it would stay open.







I found it easiest to grab the foam with both hands thumbs pointing away from each other and lift toward the top of the pak. 

Watch the water lines you don't want to pull everything out. 

Lift the foam and move it a few inches until the water lines are good and taught.







In the following pictures I moved the tube labeled MB first I found moving the tubes starting with tube AC is better because the water tubes have more room so the tubes move easier.







At this point I grabbed the foam and pulled it out sort of like pulling the table cloth off the table leaving the dishes behind only a lot slower and it was easier if I tilted the pak 45 deg.





Check the water lines to be sure they are not pinched.



Reattach the tape.



I put the pak back in the box.



I did all 10 I have on hand.

[Maggie and Jeff]

I will break my silence for this.
The problem occurred when they tried this new foam to protect the PAKs in shipping from damage. Unfortunatly the foam manufacturer gave them bad info on how the foam would expand in shipping. It expanded more than they expected causing the extra wide PAKS. I talked directly to my contact way up in the company whom I wont out. . I got the truth about 10 days ago.
I was told to try and use the PAKs if possible. I was told it is hard to damage them and it is ok to force them or play with them to get them to fit. it wont damage the inner workings. Eventually the defective ones will be gone. So try to work through this until it smooths out.

That is completely unprofessional to say the least. NxStage should recall all of these if nothing more from a business point of view in the extra costs of shipping. Unreal that a top level NxStage person would make that comment. They are now a for-profit dialysis company. Many of their latest actions are granting me no peace on how they will act as they continue to grow.

I remember when we had a similar issue with the cartages years ago.  Most of them had blood lines pinched so bad they would only work after splints were taped on the lines.  They would send replacements with the same problem for over 6 months.  Some were so bad they wouldn't even run with splints.

The pak issue is easier to deal with IMO.   

[Speedy1wrc]

I received another PAK, another too wide PAK. When I call tomorrow I am going to escalate this. What is the point? They obviously don't have a clue as to what is being shipped out and I really don't feel like getting another 5 or 10 or even 20 bad PAK's.

[Maggie and Jeff]

My advise is to fix the one you have that should get you by 6 or more weeks. 

If/When you report the pak tell them you fixed it and do not want a replacement.

Or use the big stick on them 

[Speedy1wrc]

Thanks for the very detailed writeup!

[Maggie and Jeff]

If the write up helps someone then it was worth the time and effort.

Your welcome.

[obsidianom]

Thanks for the excellant pictures.
This doesnt absolve Nxstage at all but I do want to point out other medical products and conpanies that worse things happen and they dont seem to care much either.
My wife has to use a feeding tube into her intestine to eat and drink. Without it she would be dead in a very few days. It is a life sustaining product.  We use a MIC-KEY Button which is a contraption that connects to the food line . it ebters her stoma(hole) into her abdomen and down into her intestine. It has a water filled balloon to lock it in place. Without the balloon it falls right out  and then her intestines leak out. so you can see it is critical it work correctly.
The other night we woke up at 1:30 AM to find it had come out and we had a bed full of her food and her inner fluids(yuk). But worst of all the hole ha dstarted to close quickly in the 3 or 4 hours at had been out. When we looked at it , it was apparant the balloon had failed and deflated. This button had just been put in a week earlier by me . i change them every 2 months. It took me a half hour of very stressful work to get it back in as the hole had tried to seal shut . Thankfully I had some medical instrumentsat home and could dilate it and work it in carefully. Otherwise we would have had to go to the ER in the middle of the night. It was a somewhat dangerous situation created by a defective poduct.
Well , I put a new one in and guess what!!!!. Three days later my wife was sitting at her desk at our office and suddenly let out a "oh SH---t!!.   I looked up from my desk where i was doing patient notes and saw her holding the new Mic-key button in her hand while her addomen was leaking fluid ,--AGAIN!   For the second time in a week the balloon holding the button in had deflated on its own and out it popped. Two defective buttons in a row.
I called the company that provides it for us from the manufacturer and they so far are claiming there are no reports of this happening in others . Does that sound familiar???  Hear no evil, speak no evil, see no evil??
So here is a very dangerous situation with a defective medical product and so far no admission of anything from the manufacturer.

In my office we use a lot of medical products. A few years ago a product I use for fractured bones to immonilize them was suddenly not working correctly. My patients were calling me telling me the air cells that keep compression on the fractured bone were losing air and deflating.  Not good at all!!!   Tjis was a product I had used for 15 years and was the best available . After several went bad and after numerous calls to the manufacturer asking them what was going on I kept being told nothing had changed and they didnt know why this occurred. I had my suspicions as the product was still manufactured in th U.S. which is rare . They lied at first but when it kept happening and I kept calling they finally admitted they had moved the manufacturing facility form Indiana to MEXICO. This was after they had lied and told me they hadnt moved it. Then they tried to claim that there were no differences between the old plant in Indiana and the new plant in Mexico. "everything the same.!!"    Ah ha.     It took several months and a lot of defective units before things improved.
 
So bottom line , I can go on with stories of defective medical products (like the syringes that leaked back onto me when I injected medications) by numerous companies and the lies they told about it.  Nxstage is no worse. Its just like all the other compnies out there.   Yes they should have been more forthcoming. But some of that is typical corporate behavior. No corporation likes to admit it screwed up. Coverups are common as are lies and lack of information.
I still beleive in nxstage and hope they fix this problem.

[Speedy1wrc]

nteresting and scary reading.I guess we take for granted how we think things should work, rather than how they actually do. It's somewhat prophetic but I had an interesting talk with my son last night. He's of course an amazing kid but our talk caught me by surprise. He's 20 and in most ways a typical college aged kid. But, we were talking about life and such and he was seriously worried about the future. He told me how little faith he had in his generation and where that might lead. The gist of it was that none of his friends give a d@#m about anything. It's all party and move on. We've all had similar thoughts, but to hear it from someone his age and in the context of our discussion was an eye opener.

In speaking with NxStage I am left with the impression that they don't care and they don't really grasp the impact of this problem. Tell the patient what the script says and move on to the next caller. I called today to try and escalate my problem with the PAK's and didn't get anywhere. The tech tried to go through the whole script story about the one or two units that may have slipped through the cracks before I stopped him. I told him I was well aware since I have a stockpile of bad ones here,and that it was making the internet rounds. It almost sounds like he was annoyed that he couldn't finish his speach. But he then what on to say that the problem had been fixed an no bad PAK's were going out. I informed him I just got another bad one, so maybe they still are going out. To which he admitted that there may be a "few" bad ones still in the warehouse. Sigh.

What I don't understand is that they know the bad lot numbers, so why not take a cart down to the warehouse and pull them? All they are doing Is shipping them to us to dispose of them. Fiscally that makes no sense. I am expecting another PAK tomorrow. I half want it to be bad so I can call back and hopefully get the same tech and say TOLD YA! I don't want it to be bad for one because my family room has turned into a warehouse. Secondly because I want to be done with this.

We'll see...

[Speedy1wrc]

Another day another bad PAK. My garage and family room look like a warehouse. I think I am close to ten bad ones over the last three weeks. Going through ton's of bag's and the empties are piling up. That and the leaky ones too.

I called NxStage and requested it be escalated and they refused. Yet again they started to give me the scripted spiel so I stopped them and told them I've been dealing with this for weeks, no need to repeat the talk. They really do get a bit upset when you don't let them finish. I was told it didn't need to be escalated because they have identified the problem. I told them bad PAK's are still being shipped, so the problem isn't solved. the answer to that was they have identified the problem and they aren't making any bad PAK's. I told them that's what I've been told for the last three weeks. The response was "I'm truly sorry". I couldn't make any headway, that's their story and they're sticking to it.

So, the action plan was to send me yet another PAK and more bag's. No guarantee's if would be god or not. They again "hoped" it would be good.

About 15 minutes later they called me back. The new plan is to not send ME another PAK till Monday. Hopefully by then I would get a good one. In the meantime EVERYONE ELSE will be getting them. They're going to send me a bunch of bags till then. I think I'm going to need to rent a storage unit.

[Maggie and Jeff]

Another day and 3 more wide paks.

 They called me and seeing as I am fixing the paks they would rather not send me any more which is fine with me seeing as I have 13. 12 cause I used one today.  I may not even call these 3 new ones in.