The Food and Drug Administration has issued a Class I recall of McKesson’s Anesthesia Care software following an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. The Class I recall states use of this affected product may cause serious adverse health consequences, including death.
There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death.
McKesson’s Anethesia Care solution provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care.
The FDA initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email.
