Safe Or Unsafe? Decoding Fresenius’ Dialysis Machine Recalls
Fresenius Medical Care’s dialysis machines have a disconcerting history of recalls spanning more than three years. Despite the consistent recalls, Fresenius insisted that its Liberty Cycler and 2008 Series dialysis machines were safe – until the latest recall was issued, affecting more than 111,000 machines.
Let’s briefly review the history of Fresenius’ Liberty Cycler dialysis machines:
- October 2010: Class 2 recall of Liberty Cycler sets because of leaks caused by microscopic holes in the film
- April 2012: Class 2 recall of Liberty Cycler Software because of software malfunction resulting in overfill
- February 2013: Class 2 recall of Liberty Cycler sets because of leak risks that may cause contamination
- July 2013: Class 2 recall of Liberty Cycler cassettes because of leak risks occurring during setup or during peritoneal dialysis treatment
- October 2013: Voluntary safety alert concerning Liberty Cycler machines because of fluid leaks occurring without an obvious source
- November 2013: Class 2 recall of Liberty Cycler machines because of leaks occurring inside the pump compartment
On Jan. 16, 2014, Fresenius issued a Class 2 recall for its 2008 Series of hemodialysis machines after saline bags were inappropriately filling during setup and recirculation. This recall affected 111,504 machines in North America and included the following models: 2008H, 2008K, 2008K2, [email protected] and 2008T.
What Injuries Could The Dialysis Machine Defects Cause?
A Class 2 recall involves a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. By definition, these dialysis machine defects exposed medically vulnerable patients to harm and, in some situations, severe injury.
The most common injury associated with Fresenius dialysis machine defects is peritonitis, an inflammation of the peritoneum, the thin tissue that lines the inner wall of the abdomen and covers most of the abdominal organs. This condition can be especially serious when the patient’s health is already compromised, as is typical for hemodialysis patients. In certain situations, peritonitis can cause a fatal decline in health.
Are Other Fresenius Dialysis Products Safe?
Fresenius Medical Care insists that all of its products that are still on the market are safe when used according to their instructions. However, it is the responsibility of medical device manufacturers to foresee common user errors and ensure that minor mistakes do not cause a patient serious injury or death. If a safety problem is discovered, the manufacturer must take swift action to protect the public. Fresenius has neglected those duties with not only its dialysis machines, but other products as well.
Unscrupulous Conduct Concerning GranuFlo And NaturaLyte
In March 2012, an employee of Fresenius Medical Care leaked an internal memo outlining fatal injury risks associated with its dialysate products GranuFlo and NaturaLyte. Specifically, the memo warned that GranuFlo and NaturaLyte had been tied to a high rate of cardiac arrest and death.
Instead of notifying dialysis clinics and patients of the deadly side effects of NaturaLyte and GranuFlo, Fresenius kept the news to itself – at least until it ate at the conscience of one concerned employee who leaked the memo to the U.S. Food and Drug Administration (FDA).
The FDA was justifiably outraged by the memo and began investigating the safety of Fresenius’ dialysate concentrates. It learned that certain dialysis patients had a sixfold increase in the risk of fatal heart attacks, a fact that Fresenius kept to itself. A Class 1 recall was issued, meaning there is a probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Holding Fresenius Liable For Patient Injuries And Deaths
While the FDA tries to protect the public from dangerous and defective products using its recall system, it usually takes multiple instances of serious injuries or deaths before a recall is declared. The responsibility of providing safe products rests with the manufacturer – not the government.
Fresenius Medical Care has an undeniably scary history of putting dangerous products on the market and then failing to act appropriately once it has knowledge of the defects.
Patients and families that have been affected by serious injuries or death have the right to seek legal recourse. A personal injury or wrongful death lawsuit are the proper vehicles for recovering money damages after a Fresenius dialysis product causes harm. To learn more, speak with a knowledgeable Fresenius recall injury attorney.
About Rittgers & Rittgers, Attorneys at Law
Rittgers & Rittgers is an accomplished law firm serving injured people in southern Ohio. Founded by husband-wife duo Charles H. and Ellen B. and joined by son, Charles M., Rittgers & Rittgers provides elite representation to clients with a compassionate understanding of their pain and suffering.