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McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

Tuesday, March 18, 2014

AUDIENCE: Risk Manager, Anesthesiology

ISSUE: FDA notified health professionals of a Class I recall of McKesson Technologies Anesthesia Care, a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment.

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.

BACKGROUND: 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.

RECOMMENDATION: On March 15, 2013, the firm initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email. The firm provided their customers with written copies of the communication and Clinical Alert and obtained acknowledgement that they read and understood the issue and preventive action to take. Customers with questions may contact McKesson Customer Support at 1-800-442-6767 (option 3). For questions regarding this recall, call 404-338-3556.

[03/14/2014 - Recall Notice - FDA]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm

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