Device Recall Baxter's Patient Care System 의 리콜

Recall

33250

Class 2

Z-0061-06

2005-08-29

2005-10-15

Terminated

United States

2008-02-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41544

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.

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.