Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1060-2014Class I

McKesson Anesthesia Care

Mckesson Technologies, Inc. / initiated 2013-03-15 / Terminated / root cause: software

MCKESSON TECHNOLOGIES INC. began a recall of McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through... on . FDA classified it as Class I and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1060-2014
Classification
Class I
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mckesson Technologies, Inc.
Product
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.
Product code
BSZ Gas-Machine, Anesthesia
Reason for recall
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.
Root cause tag
software
FDA root cause
Software design
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.
Quantity in commerce
10
Distribution
Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
Product codes and lots
MAC 14.3.1/MAC 14.3.1.1

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1060-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1060-2014Class ITerminatedVoluntary: Firm initiated