On March 29th of this year the United States Food and Drug Administration issued a Class I recall for two dialysis products manufactured by Fresenius Medical Care. Fresenius is a German company dedicated to the production of medical devices and products used in renal dialysis. In addition to selling these dialysis products, Fresenius also runs a number of dialysis centers. In fact, of the 400,000 dialysis patients in theUnited States, approximately 136,000 are treated using products from this company. The two products affected by the FDA recall were: GranuFlo & NaturaLyte, both of which are acid concentrates used for acute and chronic renal failure during hemodialysis. When GranuFlo is not mixed properly it can greatly increase a patient’s risk of cardiac injuries and death.
According to an internal memo sent to the physician’s practicing in Fresenius dialysis centers, if used improperly, GranuFlo could result in a patient suddenly death from cardiac arrest injuries. Alarmingly, although they were equipped with this information and sharing it within the company, FMC did not notify any of the other doctors or treatment centers with which they sold their products to. Furthermore, no notification was given to the thousands of patients treated using GranuFlo throughout the world. Steven Silvermen, the compliance director of the FDA’s medical device division said that he was “troubled by the fact that Fresenius…didn’t notify its entire customer base of this particular concern.” Especially given the fact that the consequences include serious cardiac injuries as well as death.
The recall issued by the FDA for GranuFlo was categorized as a Class I recall, which is reserved for products there is a reasonable probability that their use will result in severe medical adverse medical complications and/or death. The reason cited for this GranuFlo dialysis recall was that the concentration of acetate/sodium diacetate results in a higher than expected bicarbonate level in the patient being treated. High bicarbonate levels can result in a serious condition called “metabolic alkalosis,” characterized as pH levels outside the normal range. Metabolic alkalosis from GranuFlo dialysis can lead to cardiac injuries and death. Additionally, the FDA listed the following as serious side effects following GranuFlo use:
Oftentimes the particular brand or type of dialysis product used is not discussed with patients prior to treatment. If you or a loved one experienced cardiac injuries and/or death following dialysis treatment, you may have a potential GranuFlo lawsuit claim. Contact the Willis Law Firm today in order to discuss your legal options; you may be entitled to substantial compensation for the suffering of you and your family. We assist all GranuFlo dialysis clients on a contingency fee basis; you are only responsible to pay if a recovery is obtained.