Updated March 20, 2014, at 3:15 p.m. with comments from McKesson
The Anesthesia Care system is a database that collects and processes data on patients, including data captured automatically by patients monitors, especially in the operating room while patients are under anesthesia.
"The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care," according to the FDA notice. "The system is generally indicated in the anesthetizing environment when the anesthesia provider decides 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."
McKesson learned of 1 instance in with patient case data didn’t match patient data when the case was recalled from the Anesthesia Care Record, the FDA reported. The company promptly issued a corrective patch to the group of 10 customers with the version of software associated with the glitch, McKesson spokesman Edwards Domansky told MassDevice.com. There was no patient impact and McKesson has been keeping a close eye on the issue, Domansky added.
McKesson began issuing warnings to its customers last year, but just got the FDA’s Class I label, saying that the glitch "may cause serious adverse health consequences, including death."