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Post by Chuck Weddle on Nov 3, 2021 15:51:38 GMT
I'm a bit concerned because I have seen this carbon inside my older v8's (20k + hours) but never inside the tubing. As they are brush-less I "brushed" it off and since the machine wasn't giving me any errors...I still don't see how this could get inside the tubing given the motor construction but if that's what you folks are finding I take your word...good thing my machines are being replaced soon 0_o I'll be sure to put the ones with carbon inside on the list of those first to go! The gear pumps are indirectly coupled to the motor by magnets. It is the magnet inside of the gear pump that went bad.
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joey
Full Member
Posts: 231
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Post by joey on Nov 3, 2021 16:07:31 GMT
What Admin said! How old was your pump? Ours was 10 years old. I think its noteworthy that bleach has never touched the inside of the machine. The pumps in this machine are the original from 2006. The hours on our machines are around 45,000-50,000. We bleached on Saturdays when we first got them but a few years later we switched to strictly citric thermal. Thanks again! Let me know if you get the letter from Germany please.
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Post by SrCusEngr on Nov 5, 2021 2:20:55 GMT
You may see carbon black (an extremely fine powder that sticks and is almost impossible to clean off your fingers) on top of the piston pumps. That is from the special rubber bushing in the plastic or metal knuckle/ball joint that the piston pump arm fits into. The 'rubber' gasket of the machine can wear, as well as a FPE pump motor rubbing against a back door cover (and that one thought plastic powder all over). But inside the tubing is strictly from the magnet inside the gear pump.
They should be sealed, but after years of use, the seal wears and allows dialysate to infiltrate the magnet compartment. This will slowly react with the magnet binding material and cause it to breakdown, releasing fines into the solution. There were two Field Service bulletins from the Diaslog Advanced days that discussed this issue occurring with two different pump manufacturers. There were no concerns about the material being unsafe, just that it could cause additional labor to clean the machine. They are FSI_02/02_Dialog_Gear_Pump_Tuthill.pdf and FSI_02/06_Gear Pump Gather Internal Magnet.pdf These should still be available on the service portal.
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Post by Chuck Weddle on Nov 5, 2021 7:53:23 GMT
There were two Field Service bulletins from the Diaslog Advanced days that discussed this issue occurring with two different pump manufacturers. There were no concerns about the material being unsafe, just that it could cause additional labor to clean the machine. They are FSI_02/02_Dialog_Gear_Pump_Tuthill.pdf and FSI_02/06_Gear Pump Gather Internal Magnet.pdf These should still be available on the service portal. Aren't the pumps Micropump now?
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joey
Full Member
Posts: 231
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Post by joey on Nov 5, 2021 17:14:36 GMT
FPE and FPA were always micropump for us but the original degassing pumps for us were Gather....now all micropump.
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Post by SrCusEngr on Nov 17, 2021 19:29:28 GMT
True. But the second field bulletin was for micropumps. They then changed to a sealed version of the pump. But again, the seals do wear and since the internals are moving fluid, if the seals wear to the point of not sealing the magnet then the dialysate and citric can enter and start doing its damage over time. It is not a common occurrence but it does happen from time to time.
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Post by Chuck Weddle on Dec 11, 2021 21:04:11 GMT
It's been 7 weeks now waiting for Germany to send a letter. Don't they shut down for like a month for Christmas soon?
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btech
New Member
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Post by btech on Dec 13, 2021 13:24:59 GMT
Hey Chuck, i dont think they shut their doors for X Mas. I think they are working on a document to give us a good an information about whats going on and how to solve it. Maybe there will be an info pretty soon.
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Post by Chuck Weddle on Dec 13, 2021 15:19:19 GMT
Hey Chuck, i dont think they shut their doors for X Mas. I think they are working on a document to give us a good an information about whats going on and how to solve it. Maybe there will be an info pretty soon. I hope it's pretty soon. It's almost 2 months of not being able to use the machine because of no documentation that it's safe.
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Post by Chuck Weddle on Dec 27, 2021 11:47:05 GMT
Almost 10 weeks and nothing but crickets! If I didn't have to do without the machine this would almost be comical!
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joey
Full Member
Posts: 231
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Post by joey on Dec 28, 2021 14:20:39 GMT
Almost 10 weeks and nothing but crickets! If I didn't have to do without the machine this would almost be comical! Double UGH I was not able to find the documents that SrCus mentioned. Did you have any luck?
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Post by Chuck Weddle on Dec 28, 2021 14:42:14 GMT
I did but they weren't pertinent or what I need. Since a patient was actually exposed to this material AND there is no way to be 100% certain that its all been cleaned out...I need documentation saying that it is inert and harmless. It's my understanding that this is testing and validation that every 510(k) medical device has to have for anything that a patient could be exposed to has to have so I don't understand what's taking so long.
I know that if it was up to B. Braun USA, I would have had something the next day. The problem is that B. Braun Germany won't let USA do anything.
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Post by Admin on Dec 28, 2021 14:42:14 GMT
I may have the old old one. Maybe. I think? Maybe it was the Gather pump not the micro pump
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joey
Full Member
Posts: 231
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Post by joey on Dec 28, 2021 19:57:48 GMT
I may have the old old one. Maybe. I think? Maybe it was the Gather pump not the micro pump If you find it I would not mind having it sent to me as well please.
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Post by Chuck Weddle on Jan 11, 2022 13:23:32 GMT
UPDATE:
Pretty much there is no update! It has now been 10.5 weeks without the use of an otherwise perfectly good piece of equipment. Being down a machine while having to dedicate machines as COVID+ machines really puts a damper on things.
Supposedly, a PIR has been filed in the hopes of getting some kind of response from QA at least. Keep in mind that a "customer complaint" was filed back in October and there has been nothing official on that.
I'm starting to feel like I'm dealing with Fresenius!
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