I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: Florida Lawyer on March 20, 2013, 07:35:13 AM
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The recall had nothing to do with faulty product. The recall wasn't even a full recall because nothing needed to be shipped back to the manufacturer, it was just to inform that they were changing the labeling to make the perscribing of the product more clear. The deaths that have occurred in FMC, Davita and any other company that uses FMC's product has to do with how it is perscribed by the MD. The way it works is that a patient should have a certain bicarbonate level that gets tested through blood lab work. If that level is out of range then your prescription/treatment could be tweaked accordingly. Before a treatment your machine is set to deliver a certain bicarb level. Generally that level is universal for all patients in a clinic. If a clinic wants lets say a final bicarb outcome of 38 and they are using a Granuflo that was mixed in house then the machine should be set for 30 because your body metabolizes some of the Granuflo and makes the additional 8. If you are using a specialty bath in an individual jug or from a drum then it would be set for 34 because it is a slightly different mix and you only get an additional 4. The problem was/is that if the prescription was for 38 the machines were being set for 38 which gives you an outcome of 46 which is too high. There have been memos and letters and in-services done for as long as I can remember now to prevent such things from happening. The product is safe it's the human error that caused the injuries/deaths.
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I'll see if I can dig up the URL when I have time, but Fresenius has a great on-line training slide deck dealing with the Granulite, Naturalyte, and Citrisafe products explaining the chemical reason for the +4 or +8, and the need to account for the difference when prescribing. It's a good read if you remember you basic chemistry.