Home Dialysis Machine Recalls
Baxter International has recalled one of its peritoneal dialysis solutions devices amid concerns about mold contamination and reports of dangerous side effects for patients.
The Dianeal PD-2 Peritoneal Dialysis Solution Recall was announced on March 5, 2014. Baxter had received complaints about solution that had turned into mold. A number of adverse patient events have also been reported by dialysis patients who were given the solution.
In addition, there have been reports of adverse events, including death for the home health dialysis machines. The announcement stated, “Intra peritoneal administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.” The company believes the contamination may have been caused by a leak in a container.
The FDA issued a Class 1 recall for several models of BaxterHomesChoice automated dialysis systems because of a defect that can cause machines to overfill a patient’s abdominal cavity with fluid. There have been reports of at least one death because of this problem. There be many more deaths associated with the overfill defect.
Baxter and the FDA sent letters to healthcare professionals on Wednesday, March 5, 2014 notifying them of the BaxterHomesChoice dialysis machine recall. Because of the classification of a “Class 1”, the medical device recall means that the defect has a likelihood of causing serious injuries or death. It has been confirmed that at least one death and several serious injuries have occurred among those who have used the dialysis machines that overfilled their abdominal cavities.
Dialysis is a replacement for kidney function in patients who suffer from kidney failure. Peritoneal dialysis machines like the BaxterHomesChoice and BaxterHomesChoicePro devices pump a sterile glucose solution into the abdominal cavity around the intestines. The solution then absorbs waste products from blood through osmosis before being drained out of the body. The advantages of peritoneal dialysis are its use at home by patients without required medical assistance. But caretakers for those using these devices must be very well acquainted with the procedure. Baxter does not provide at-home training for home health caretakers using its dialysis machines.
Increased intra peritonea volume (IIPV) can cause a number of serious medical problems, including death, abdominal wall or diaphragmatic hernias, heart failure, acute hypertension, pulmonary edema, decreased lung function, pericardial effusion or excess fluid around the heart and peritonitis, which is a potentially fatal inflammation of the lining the abdomen or infection of the peritoneum.
Symptoms of overfill in patients, according to the Baxter press release regarding signs of IIPV include, but are not limited to:
- Difficulty breathing
- Feeling full or bloated
- Abdominal pain or discomfort
- Swelling of the genitals, arms and legs
- Leakage of fluid from the peritoneal dialysis catheter
- Increase in blood pressure
The Baxter recalls for the BaxterHomesChoice Automated Peritoneal Dialysis Systems correspond with these product codes 5C4471, 5C4471R, 5C4474, 5C4474R, P5C441, P5C441R, 5C4474D and 5C4474DR. The Baxter recall also includes the BaxterHomesChoice Pro Automated Peritoneal Dialysis Systems with the product codes: 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300 and T5C8300R. These systems have been in the marketplace in varying forms and distributed to patients since 1994.
The FDA has warned that patients and caregivers should be on the watch for any signs of IIPV. If any of those symptoms and signs is noticed, device should be stopped immediately and a manual drain initiated. A doctor should then be contacted without delay.
If you or someone you know has been injured as a result of one of the defective BaxterHomesChoice devices or another medical device defect, please call us for an immediate free consultation.
Robert Kreisman of Kreisman Law Offices has been handling medical device defect injury cases. Kreisman Law Offices has prevailed in trials and settlements in Chicago, Illinois and surrounding communities and has successfully resolved cases for those injured in medical device defect cases.
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