FDA publishes its warning letter to Baxter over home dialysis and infusion devices

The HomeChoice dialysis device--Courtesy of Baxter
A HomeChoice dialysis device--Courtesy of Baxter

A Baxter Healthcare plant in Illinois failed to put in place adequate quality control practices in the manufacture of HomeChoice dialysis and iPump pain management systems, the FDA tells the company in a warning letter.

Quality control problems at the Round Lake plant go back more than a decade. In 2002, the FDA warned the company that the facility wasn't in compliance, according to a Chicago Tribune report published at the time. This round of problems stems from inspections in April and June of 2012. Baxter has been working with the FDA to address the problems at the plant, according to the warning letter dated Jan. 17, which the FDA published this week.

Baxter Healthcare Corp. is the medication delivery subsidiary of Baxter International. The FDA letter alleges Baxter knew components were failing in its HomeChoice peritoneal dialysis devices, but simply replaced the components, without establishing the cause of the failure. The devices are used for home dialysis by patients with kidney disease.

Similarly, Baxter didn't take corrective action when its iPump intravenous infusion devices overinfused. The IV devices are used for pain management. In cases involving the drugs fluorouracil, morphine, vancomycin and fentanyl citrate, the devices "had over delivery times that were between 20 and 48 hours prior to the expected delivery time," according to the letter.

In addition, the FDA cited Baxter for failing to adequately track complaints about its products. Baxter received 186,822 complaints between April 17, 2012 and July 2013, but didn't have the statistical tools in place to know when the volume of complaints was trending, according to the FDA.

Last month, Baxter disclosed that it had received the letter. The company said at the time it did not expect any impact on product availability.

- read the FDA's warning letter
- here's a brief on Baxter's disclosure

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