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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter's Patient Care System

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 Class 2 Device Recall Baxter's Patient Care Systemsee related information
Date Initiated by FirmJune 16, 2005
Date PostedOctober 08, 2005
Recall Status1 Terminated 3 on February 06, 2008
Recall NumberZ-0033-06
Recall Event ID 32449
Product Classification unknown device name - Product Code NSX
ProductBaxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
Code Information Software version 4.1-77, 4.0-66 and 3.4-18.24
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.
FDA Determined
Cause 2		Other
ActionUrgent Device Correction recall letters dated 6/16/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the Administration Unit of Measure (AUOM), and informed the accounts that changing the AUOM of an ordered drug presents a patient safety issue resulting in a potential for a medication error. The accounts were requested to eliminate or minimize any further AUOM changes until a software upgrade is available. If an AUOM change is required the pharmacy end user must contact the Baxter Patient Care Helpdesk at 1-877-835-2727 prior to any changes being made. A Technical Bulletin was provided with the letter to guide the pharmacy end user through the process of an AUOM change with the aide of a Client Support Specialist.
Quantity in Commerce5 units
DistributionMissouri, Massachusetts, Vermont, California and Canada.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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