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Post by Chuck Weddle on May 17, 2022 19:55:56 GMT
This isn't a recall, at least not yet but, I wanted to spread the word about an issue we discovered this morning with the Streamline Bloodlines. We only use Braun machines so I don't know if the lines for Fresenius machines could be having the same issue or not. We have found this issue with at least 3 different Lot #'s which I'm told are from at least 2 different assembly locations. When the staff were told about this, they said that its been happening "since last week".
The issue:
The membrane in the arterial POD is apparently stuck to the "blood side" of the POD while in the package. The membrane doesn't become "unstuck" during priming (at least not in all cases). The membrane is not easily seen until there is blood in the line. We have seen arterial pressures typically around -76 so the machine doesn't alarm. Turning off the blood pump does not result in the POD filling even when the pressure line is disconnected and open to atmosphere. However, the POD membrane is easily adjusted manually with a syringe and the treatment continues with normal pressures.
This has been reported to B. Braun.
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Post by Chuck Weddle on May 24, 2022 9:19:35 GMT
UPDATE:
The issues continue. Fortunately (or not), since the staff know how to look for this and fix it now, I'm not getting the reports that I should be getting.
The B. Braun nurse that I am reporting these issues to told me that they saw the same problem last summer and it was thought to have been caused by high temperatures during transit. When I asked why customers weren't alerted she responded with "it was felt to not be an issue because the clinical staff should notice it". This did not sit well with me! In the real world, dialysis staff adapt and overcome. The problem either goes un-noticed because the machine DOES NOT ALARM or, they notice the problem and fix it. This does not negate the fact that the issue shouldn't be happening in the first place!
Now, "Medical Affairs" are involved and are in damage control mode saying "I believe the conversation ***** (name removed) had with you was anecdotal...". BS!
They also say that I "won't" send them samples to examine which is total BS! What I told them at least twice was that we don't have the supplies to safely ship biohazard samples but if they would send me the needed supplies, I would send samples. This request goes ignored.
I still whole heartedly believe that the Dialog+ machines are the best on the market and their Tech Service guys have no equals. These in-house pinheads however are making the company seem more and more like Fresenius.
I think it may be time for B. Braun to change their motto of "Sharing Expertise" to something else.
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Post by Chuck Weddle on Jun 2, 2022 13:21:34 GMT
UPDATE #2:
We continue to have this problem at 1 facility with what is now a single Lot# (00VL809584). I suspect we our having issues at other facilities and likely other Lot #'s but they are going unreported.
Supposedly, Braun has not been able to reproduce this issue with retained samples of the Lot#'s we have seen it with. However, they do at least appear to be taking it seriously now because they are sending a nurse in to us in order to observe them in use in the field.
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Post by qman213 on Jun 2, 2022 16:35:03 GMT
I just spoke with one of our managers and we are also seeing a few of these.
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Post by Chuck Weddle on Jun 2, 2022 16:41:02 GMT
I just spoke with one of our managers and we are also seeing a few of these. Please make sure they report it. According to Braun, we are the only ones! |
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Post by qman213 on Jun 2, 2022 17:46:16 GMT
Done.
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Post by Chuck Weddle on Jun 15, 2022 18:58:11 GMT
UPDATE #3
Two nurses from B. Braun were at one of our facilities with me for the last day and a half as well as their Medical Affairs nurse today. They were able to witness the issue as well as have it happen to them when they set up a machine. This verified our claim that it was not being caused by something our staff were doing. I then showed them the physical difference of the POD between an affected line and an unaffected line (same Lot#). They also now understand that asking a customer to somehow safely package and ship biohazard samples is not a reasonable expectation. They are looking in to acquiring the proper material that they would be able to send to customers in the future.
I have devised a work-around for this issue.....
We will be changing our priming procedure to incorporate this work-around. This change does not affect anything else so it will be permanent with no need to switch back after Braun finds the root cause and fixes it. The Braun nurses like this change and may explore changing it in their official procedure also.
As written now, the arterial pressure line is supposed to be connected to its monitor port before the system is primed. The change is to not connect the arterial pressure line until after the lines are connected to each other and the system is recirculating but BEFORE the dialysate lines are connected to the dialyzer. Doing this allows the POD to reposition itself without needing to manually do it with a syringe.
IMPORTANT: The VENOUS pressure line must still be connected to its monitor port BEFORE priming the system.
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