The Food & Drug Administration warned Baxter Healthcare Corp. (NYSE:BAX) that it has 15 days to respond to the watchdog agency’s concerns about its HomeChoice peritoneal dialysis systems, after reports surfaced of at least four patients developing peritonitis.
In a June 3 warning letter sent to Baxter chairman, president and CEO Robert Parkinson Jr., the FDA said Baxter failed to notify its Center for Devices & Radiological Health about “individual adverse events no later than 30 calendar days after the day that you receive or otherwise become aware of information” suggesting that the HomeChoice system may have “caused or contributed to a death or serious injury.”
In one case, according to the letter, a pediatric patient developed peritonitis after suffering loss of appetite, diarrhea and slower drain times.
“Based on the limited information in the complaint file, the device’s decrease in drain time may have caused or contributed to peritonitis in the patient,” according to the letter. “This complaint should have been submitted as a serious injury MDR event.”
In another instance, a patient developed peritonitis, with a nurse opining that it was unlikely that the HomeChoice device caused the event.
“It is not clear what role this nurse had in the care of this patient’s device prior to admission to the hospital, or what was the technical or scientific basis for this opinion,” according to the letter. “The documentation indicates that the patient had difficulties with the device and subsequently experienced peritonitis. Lacking an investigation by your firm to determine whether the device may have caused or contributed to the reported patient outcome, the event should have been submitted as a serious injury MDR event.”
In a third case, the letter said a patient “contacted your firm for help in ending therapy in order to go to the emergency room” and was later admitted to the hospital for peritonitis.
“Your firm had evidence that the patient had difficulties with the device and subsequently experienced peritonitis,” according to the letter. “There is no information about the type of difficulties the patient experienced with the subject device or whether or not the ‘low drain’ could have resulted in a clot on the device and therefore may have caused or contributed to peritonitis. Lacking evidence that the device did not cause or contribute to the patient outcome, the event should have been submitted as a serious injury MDR event.”
And another patient twice developed peritonitis, blaming a portion of the device for retaining water during showers.
“The documentation includes a statement that ‘since the patient started wrapping the minicap in a plastic bag prior to showering, no further episodes of peritonitis have occurred,'” according to the letter. “Events involving user error are reportable whenever the use of the device may have caused or contributed to a reportable death or serious injury. This event should have been reported to FDA as a serious injury MDR event.”
Baxter reports all cases of peritonitis to the FDA’s Center for Drug Evaluation & Research, according to the letter, but the agency countered that Baxter must report such cases to the CDRH.
“We have reviewed your response and have concluded that it is inadequate. Your response indicates that your firm reports all cases of peritonitis to CDER, and should not have to report to CDRH,” according to the letter. “Submission of peritonitis events to CDER does not satisfy the reporting requirements. … Reporting medical device related events to CDRH does not constitute undue burden or duplicate reporting to the FDA; medical device related events should not be submitted to CDER, and by doing so constitutes a failure to comply.”
The FDA also flagged Baxter for failing to timely report at least three problems with a component of the HomeChoice system that “may cause a breech in the sterile pathway that exposes the patient to the risk of bacterial contamination and infection which reasonably suggests that the malfunction would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
“We have reviewed your response and have concluded that it is inadequate. Your response states that you had no evidence of a device malfunction for the events listed above,” according to the letter. “However, information in your complaint files does not provide any evidence to justify your position.”
Baxter has 15 days from its receipt of the letter to respond.
It’s not the first time the HomeChoice system has created serious problems for patients and for Baxter. In March, the FDA issued a Class 1 recall for several models of the device, saying a problem with the dialysis machine is causing “increased intraperitoneal volume” or an overfill of the abdominal cavity with liquid, leading to injuries and at least one reported death.
