Fresenius Recalls Dialysis Concentrate, May Be Contaminated

Fresenius Medical Care North America has announced the voluntary recall in the United States and Canada of a total of 56 lots of its 6.4-liter Fresenius NaturaLyte Liquid Bicarbonate Concentrate, which is used in dialysis machines, for potential bacterial contamination.

The voluntary recall was reported to FDA, which has given the recall its the most serious Class I designation. FDA says it has received one report of death and two reports of injury that may be related to use of this product. Further, use of the affected product "may cause serious adverse health consequences, including sepsis, bacteremia, and death."

An initial recall of 49 lots was announced on April 10, followed by an expanded recall on May 1. A link to a list of the recalled lot numbers is provided here.

According to Fresenius, "(t)he affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company's internal specification during their shelf life.

"Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt concentration). According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely."

Since Fresenius is both the producer of the liquid concentrate and uses it in its network of about 2150 dialysis centers, this recall may have been easier than most. This might possibly explain the duplication of two of the lot numbers in both lists of recalled lots - they hadn't yet received all of those two lots at the time of the expanded recall.

Writing for FiercePharmaManufacturing.com, Nick Paul Taylor notes that "While dialysis machines use filters to stop bacteria or endotoxins reaching patients, case reports suggest this precautionary measure can fail. Writing in the journal Medicine in 2009, staff at a renal care center reported they found bacteria in the blood of two of their patients within days of each other. An investigation led the team to conclude that Halomonas bacteria have pathogenic potential."

Fresenius Medical Care is one of four arms of Fresenius SE & Co. KgaA, which makes its headquarters in Bad Homburg, Germany. The other three business units are Fresenius Kabi, which develops, produces, and markets pharmaceuticals and medical devices for the therapy and care of critically and chronically ill patients; Fresenius Helios, which owns and manages 109 hospitals; and Fresenius Vamed, which constructs and manages hospitals and healthcare facilities worldwide.

Stephen Levy is a contributor to Qmed and MPMN.