It could have been a happier new year for a home peritoneal dialysis patient who reported being overfilled with a dialysis solution by a Fresenius Liberty Cycler, a medical device which, according to the U.S. National Institutes of Health, fills and drains the abdomen with a cleansing solution that helps to extract from the blood “wastes and extra fluid.”
That patient was fortunate though, according to a U.S. Food and Drug Administration adverse-event report from the manufacturer dated New Year’s Day 2013, because there were no reported long-term ill effects.
On the other hand, the defective medical device lawyers at Reich & Binstock have been contacted by the family of a former Liberty Cycler patient who appears to have been victimized by an apparent software malfunction that led to her untimely death.
The Liberty Cycler’s manufacturer, Fresenius Medical Care, sent letters to patients in March and in April of 2012, consistent with its recall of cycler software that preceded version 2.8. The reason for the recall, according to the FDA’s enforcement report dated May 23, 2012, was the “increased risk of intraperitoneal volume (IIPV), referred to as overfill.”
The device maker’s April 3, 2012, letter noted that Fresenius had “received reports of patients experiencing increased intraperitoneal volume,” which is “when you have too much fluid in your abdomen. The letter requested that patients confirm the software version installed on their machines.
It further ominously read, “Overfill/IIPV may be caused by inadequate drainage, and may result in serious injury or death.”
A copy of that letter reached the decedent’s residence. Unfortunately, she didn’t live to see it. The letter arrived several days after she had passed away from apparent overfill complications.
The manufacturer needs to be held accountable for this. Indeed any medical-device manufacturer must be held accountable for injuries, fatal and otherwise, arising from the use of a defective product.
# # #
Anyone or a family member of one who has suffered an injury due to overfill from Liberty Cycler peritoneal dialysis treatment may contact one of the defective medical device attorneys at Reich & Binstock for a free consultation. Such a patient may be entitled to compensation. The law firm may be reached toll-free at 1-866-LAW-2400. The firm’s website is www.reichandbinstock.com.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.