The bacterial contamination that caused a recall of NaturaLyte liquid bicarbonate concentrate last month has been identified and Fresenius Medical Care has expanded the recall due to the risk of severe injuries or death among dialysis patients.
On May 21, Fresenius Medical Care North America expanded a NaturaLyte recall first issued in April, due to bacterial contamination.
The company announced that the bicarbonate concentrate, used in dialysis procedures, was contaminated with a bacteria called Halomonas, and that the FDA has classified the decision to remove of the 56 lots of affected NaturaLyte as a Class I recall, suggesting that continued use of the product may carry a risk of severe adverse health outcomes or death.
The recall was first announced in a letter sent to healthcare professionals on April 10. A second letter was sent out earlier this month, the company said.
Fresenius reports that Halomonas is a Gram Negative bacteria that is usually found in water with high levels of salt. Exposure to Halomonas in NaturaLyte could lead to bacteremia or systemic infection, and patients requiring dialysis may be more vulnerable to such infections. However, Fresenius notes that the dialysis procedure utilizes both the dialysis filter, known as a dialyzer, and the use of the Diasafe filter or an equivalent which makes infection unlikely.
The NaturaLyte recall expansion increases the amount recalled from 49 lots to 56 lots of NaturaLyte Bicarbonate Concentrate sold in 6.4 liter bottles, which were distributed between August 15, 2013 and April 7, 2014. The affected lots contain a product code of 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
Fresenius warns that bacterial contamination could cause pyrogenic reactions from endotoxins present in bacteria, which can lead to fever, hypotension, flushing, chills, and potentially trouble breathing. While most of these symptoms are short-term, contamination could also lead to long-term health consequences.
The manufacturer has requested that dialysis clinics with bottles of NaturaLyte affected by the recall discontinue use immediately, place the recalled bicarbonate concentrate in a secure, segregated area, perform a [Heat Disinfect] program on any machine on which affected product was used, and contact a Fresenius service team by calling (800) 323-5188 for instructions on how to return the recalled NaturaLyte. The letters included a reply form the company wanted customers to fill out and return as well.
NaturaLyte Heart Attack Lawsuits
The recall comes a little more than two years after it was discovered that Fresenius withheld important safety information about the risk of cardiac arrest linked to the use of NaturaLyte and another dialysate solution known as Granuflo, a dry acid concentrate.
Fresenius Medical Care not only makes many of the products used during dialysis treatment, but also operates many of the clinics in the U.S.
In November 2011, the company sent an internal memo to their own clinics warning about the importance of doctors monitoring bicarbonate levels during treatments, since side effects of Naturlyte and Granuflo may cause higher than expected bicarbonate levels and cause dialysis patients to suffer a sudden cardiac arrest or death.
While Fresenius provided these warnings to their own clinics, the information was withheld from other dialysis clinics using the products. After the internal memo was leaked to the FDA, Fresenius finally provided warnings to the entire medical community in March 2012, which the FDA classified as a NaturaLyte and GranuFlo recall.
More than 1,500 Fresenius dialysis treatment lawsuits are now being pursued by individuals throughout the United States who allege that sudden cardiac arrest or death following hemodialysis was caused by use of NaturaLyte or Granuflo.
In the federal court system, the litigation has been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts for coordinated handling during pretrial proceedings and a series of bellwether trials designed to gauge how juries are likely to respond to certain evidence and testimony that will be similar to what is offered in hundreds of other cases.