A Dialysis patient and KidneyBuzz.com viewer wrote, "Fresenius Medical Care Dialysis keeps recalling my supplies. I just found out in a certified letter that I have been using contaminated Bicarbonate Concentrate (ready-to-use Dialysis fluid). If they are not careful, they will kill me with these errors."
As most Chronic Kidney Disease and Diabetic patients know, a recall is when a product is removed from the market or a correction is made to the product because it is either defective and/or potentially harmful. In the case of the most recent Bicarbonate Concentrate voluntary recall, Fresenius Medical Care said "they have determined the product may contain higher levels of bacterial contamination than allowed by their internal specification."
This is a serious matter as Injury Lawyer News recently reported that a Former Fresenius Dialysis patient, "alleges that use of Granuflo or Naturalyte (Bicarbonate Concentrate) during his Dialysis Treatment led to a Heart Attack at a Fresenius Clinic." Similarly, Nephrology News reported last year that the U.S. Food and Drug Administration (FDA) received a report of death and two reports of injury that "may be related to use of recalled lots of Fresenius Medical Care North America's NaturaLyte liquid Bicarbonate Concentrate."
The most recent Bicarbonate Concentrate recall is just one (1) of the fifty-eight (58) other lots of Dialysis Fluid Concentration recalled for the same reason since last year. This comes on the heels of a massive voluntary recall of the Fresenius Medical Care 2008 Series Dialysis Machine (still in circulation) due to a defect of the Dialysis Machines' saline bags inappropriately filling during Priming and Recirculation. Fresenius was able to team with the FDA and notify Chronic Kidney Disease patients as well as Dialysis Clinics about the malfunction, and correct the issue while, "keeping the product in the field."
Due to the fact that Fresenius Medical Care, is the Largest Dialysis Organization in the United States and treats approximately 400,000 Dialysis patients, what may be considered "frequent recalls" by some patients is a bit alarming. However, Fresenius is not alone. Just last month, Baxter Healthcare (one of the largest producers of Intravenous Saline in the country) voluntarily recalled nearly 600,000 units of Sodium Chloride Injection (IV Saline) because of concerns about sterility, according to Medscape.com. That is the sixth recall of Saline Solution products by Baxter in the past 15 months.
Recommended Reading: Is Use of Heparin in Dialysis as Safe as Dialysis without Heparin?
Likely, most patients want to know, "How can I protect myself from side effects such as Cardiac Events and even death due to contaminated or recalled items?" The answer is, unfortunately, that there is not much a patient can proactively do. However, there are some actions that Chronic Kidney Disease patients who conduct Dialysis may take to improve their safety and mitigate against risk:
1.) If you feel something, say something! If you do not feel well or have unusual side effects after Dialysis such as your heart racing uncontrollably, contact your Healthcare Team immediately. If it is an emergency, then go straight to the emergency room.
2.) Check your mail. Usually, your Dialysis Clinic will send you a notice by mail letting you know that a product or solution is being recalled. Hence, be on the lookout for such notices so you do not accidentally throw your notice in the waste bin as "Junk-mail."
3.) Sign up to be among the first to receive new recalls and safety information electronically. Enroll in this FREE service by completing the below form and getting direct notifications of recalls from the U.S. Consumer Product Safety Commission and the Food and Drug Administration.
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