The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities.
According to an Aug. 12 warning letter posted online, Masimo received complaints regarding inaccurate readings of its Rainbow SET Pronto 7 Pulse CO-Oximeter, but the complaints were not evaluated using appropriate parameters. The company’s documented reviews didn’t identify the comparator that was used and failed to evaluate the device at the range of hemoglobin readings cited in the complaints.
The company determined that the issue was unlikely to cause or contribute to a death or serious injury, but the records of its investigation didn’t include required information regarding the nature and details of the complaints, the warning letter says.
During the Aug. 13 to Oct. 3, 2013, inspection, the FDA also found that Masimo failed to establish and maintain procedures for implementing corrective and preventive actions.
For example, the company’s CAPA didn’t address whether any manufactured product could have been affected by the manufacturing nonconformance. And it failed to explain whether a review of complaints and device history records should have been conducted to pinpoint all products possibly affected by the nonconformance, the letter says.
The FDA investigator also cited Masimo for failing to investigate the cause of nonconformities, the letter notes.
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