FDA Recall Terminated

McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. 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. 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.

Recall: Z-1060-2014 · Initiated March 15, 2013

Recall

Recall Number
Z-1060-2014
Event Number
66287
Firm
MCKESSON TECHNOLOGIES INC.
FEI Number
3009662297
Product Code
BSZ
Status
Terminated
Root Cause
Software design
Initiated
March 15, 2013
Posted
March 5, 2014
Terminated
May 1, 2014
Address
300 West Morgan St, STE 200, Durham, NC, 27701

Description

McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. 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. 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.

Reason

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.

Action

McKesson sent a Clinical Alert dated March 15, 2013 to all affected customers. Additionally, phone calls were placed to each customer, followed up by an email to provide them written copies of the communication and Clinical Alert and obtaining acknowledgement that they have read and understand the issue and preventive actions to take. Customers with questions were instructed to contact McKesson Customer Support at 800-442-6767 (option 3). For questions regarding this recall call 404-338-3556.

Distribution

Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.

Quantity

10