GRANUFLO - FMC

[anurseadvocate]

Has anyone been following the recent expose' of FMC's Granuflo and the FDA recall?

[Rayden]

Yup, I have been following it.

Here's an update,

FDA Places GranuFlo, NaturaLyte Under Serious Recall Category

[zero.]

The word "serious" combined with "recall" would really raise eyebrows.

Thanks to allnurses.com, issues like this spread across us professionals like wildfire.

[anurseadvocate]

Zero - do you work at an FMC unit? If so, were you aware of this - or if you work at a Davita unit, or other unit, were u aware of such --- FMC should have, and apparently they did not, send the information to their non-owned facilities that they sell granuflo to --- I noted someone else posted a link so here is the link that shows all the background information from start to recent -- although, yesterday a recall went out again wtih FMC's information on it

Untitled Document I hope it is ok to post this link as it give all the detailed information for you and other professionals...

Anurseadvocate

[zero.]

No I don't work in an FMC unit.

However we do use Granuflo right from the start, when the dialysis unit was established 3 years ago. And on the other thread I have learned about this issue only last March when FMC released the advisory for external clients. I share the same sentiment as to why they waited until March of 2012 when FMC already knew about the issue and released an internal memo regarding it in November last year.

Even before the recent serious recall from the FDA, I already brought this topic up in our clinical sessions the moment I got aware of the issue. Short term plan was to adjust dialysate settings individually every two weeks, and long term was to shift from Granuflo to Citrapure. We are just consuming the rest of the Granuflo stocks, and waiting for the initial Citrapure orders to arrive.

Better to be safe than sorry.

[anurseadvocate]

I mentioned in another thread that I have communicated with an expert who actually does 'expert witness' positions in dialysis and this person stated that it is still quite risky and you are taking a real risk to continue using such.. but good that you asked the questions you did and this is part of the situation is that FMC units were made aware but other units werent thereby placing patients in harms way, or potential harms way

[zero.]

Yes, ideally the usage of the product in question should be stopped immediately, but it would then be a logisitical nightmare for us dialysis managers and staff since we don't have an alternative acid concentrate to use in the meantime. We would end up closing the dialysis unit until the citric based dialysate arrives. So right now we are exercising utmost precaution and care during this critical period. It's just a matter of weeks.

In my experience, this is the 3rd product from FMC that had to be recalled. I remember those Combiset bloodlines that had kinks on the segment for the BVM slot, and the defective powercords for 2008K and K2 machines. We actually had 2 of those machines that had the entire plug melted, and thank God no other serious event happened.

[anurseadvocate]

WOW, I never know of that recall..... pretty scarey and this is probably why it is important to have only well expertised dialysis nurses - but with the federal Conditions, as they are -- there are only minimal requirements for RNs and technicians -- even with the mandated certification of techs, we are still seeing major problems in delivery of care but the real basis of the problem is that staff are not fully familarized with the facility's policies and procedures -