A recall of Baxter International’s <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">HomeChoice and HomeChoice Pro peritoneal dialysis cyclers that was issued last month has been designated a Class I recall by the U.S. Food & Drug Administration (FDA). The recall was given Class I status because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with the use of HomeChoice and HomeChoice Pro peritoneal dialysis cyclers.
HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. Model numbers affected by this recall include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR.
According to the recall notice, the action was taken because of reports of patients overfilling their abdominal cavities, a complication known as Increased Intraperitoneal Volume (IIPV). IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. According to Baxter, children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Baxter has advised patients and caregivers to watch for the potential signs of IIPV. These include: difficulty breathing; vomiting or spitting up; a child complaining of a “funny feeling” in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure.
If patients or caregivers notice any of these symptoms, they should stop the device, initiate manual drain, and contact their healthcare provider immediately. Additional information that will be relevant in assessing patients for IIPV includes: careful monitoring of pre- and post-treatment weight; evaluating vital signs including heart rate and blood pressure; review of the recorded ultrafiltration from the device; and development of symptoms of respiratory distress or increased effort in breathing. For patients in a clinic, hospital, or critical care setting, clinicians should consider increased monitoring. This would include evaluating oxygen saturation and evidence of abdominal tenseness.
The recall notice does not require the physical return of HomeChoice units and patients may continue using them. Baxter’s recall notice said it was important that clinicians review the prescription settings for devices to help reduce prescription errors and weigh the risks and benefits of continued use of this device by their patients.
Baxter said it is still investigating the source of the problems and is working on
changes to labeling and software to prevent patient errors.