Baxa Warned for Not Reporting Adverse Events to FDA

Baxa failed to report two serious injury complaints to the FDA because the injuries were caused by user error. However, medical device reporting (MDR) requirements specify that such events must be reported, an FDA warning letter says.

The complaints, received in 2006, indicated patients suffered serious injuries after receiving incorrect concentrations of solutions.

Baxa manufactures electromechanical infusion pumps and related sterile tubing sets; electromechanical pharmacy compounders, mixers and mixing-filling equipment; and other sterile and nonsterile pharmacy accessories.

During its inspection of Baxa, the FDA reviewed another 19 complaints about inaccurate or incorrect delivery. Those complaint records did not contain sufficient patient information to evaluate the events for MDR reportability, and the records did not give reasons for the lack of patient information and MDR evaluation, the letter said.

The company also did not ensure all complaints involving the possible failure of a device to meet specifications were investigated, according to the warning letter. The agency’s review of complaints related to Baxa’s EM2400 compounder found reports of boot-up failures, bubble detectors not working properly and intermittent lockup on the touch-screen display.

The warning letter, posted recently to the FDA website, can be seen at www.fda.gov/foi/warning_letters/s6691c.pdf.