McKesson Anesthesia Care Recalled over Patient Data Issues

The FDA has issued a Class I designation over McKesson Technologies Inc.'s recall of its McKesson Anesthesia Care, a computer-based system used in environments such as operating rooms.An anesthesia provider uses the system to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. But there was an occurrence where a patient's data in the system included information from another case, the FDA said when announcing the Class I designation on Friday.FDA officials think mismatch of patient data related to anesthesia delivery could cause serious injury or death.McKesson Anesthesia Care collects data both through manual entry and from monitors which are attached to patients.Alpharetta, GA-based McKesson Technologies Inc., which is part of San Francisco-based McKesson Corp., issued a Clinical Alert in March 2013 over the issue, calling customers on the phone and following up with email.

There have now been at least eight serious medical device recalls and warnings announced by the FDA since January.

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Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.