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U.S. Department of Health and Human Services

Class 1 Device Recall McKesson Anesthesia Care System

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 Class 1 Recall
McKesson Anesthesia Care System
see related information
Date Posted March 05, 2014
Recall Status1 Terminated on May 01, 2014
Recall Number Z-1060-2014
Recall Event ID 66287
Premarket Notification
510(K) Number
K113633 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
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.
Code Information MAC 14.3.1/MAC 14.3.1.1
Recalling Firm/
Manufacturer
MCKESSON TECHNOLOGIES INC.
300 West Morgan St
STE 200
Durham, North Carolina 27701
For Additional Information Contact Paul Sumner
404-338-3556
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = MCKESSON TECHNOLOGIES INC.
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