Baxter Healthcare has reported that the FDA has classified its recent Urgent Product Recall regarding increased intraperitoneal volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall.
The action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Baxter has received serious injury reports and at least one patient death report associated with this issue, over the previous two years.
Baxter is continuing to investigate the causes, fixes, and mitigations associated with IIPV and use of the HomeChoice device. Current mitigations under development and implementation include changes to device labeling and software, which are intended to address issues such as prescription and patient errors, including bypassing alarms.
Baxter has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA midyear. The software update will include additional user interface messages and alarms, and change default settings and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavity.
HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis.
The recall notice does not require the physical return of HomeChoice units and patients may continue using them. Affected model numbers include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR. It is 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 that it has sent recall notices to clinicians and patients informing them of this action and identifying steps that are intended to reduce the harm associated with IIPV.
Bruce McGillivray, president of Renal business at Baxter, said: “We are committed to providing peritoneal dialysis patients with the safest and most effective therapy possible. We stand ready to support our patients and the nephrology community as we develop and implement measures intended to reduce the occurrence of IIPV.”