Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care -

FDA device recall Z-0061-06 · posted 2005-10-15 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.

Action taken

Urgent Device Correction recall letters dated 8/29/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the modification or creation of a Monitoring Parameter, and informed the accounts that modifying the Monitoring Parameters could result in a potential for a patient receiving an incorrect medication or an incorrect medication dosage. The accounts were advised that administrative end users should never modify the seven pre-defined Monitoring Parameters or create new Monitoring Parameters.

Root cause

Other

Status

Terminated

Product code

LNX

Quantity affected

5 units

Distribution

Missouri, Massachusetts, Vermont, California and Canada.

Date initiated

2005-08-29

Date posted

2005-10-15

Date terminated

2008-02-06

Location

Round Lake, IL