BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER PCA II

    MDR report key: 2933604 · Received January 25, 2013

    Report

    Report Number
    2933604
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 25, 2013
    Manufacturer
    BAXTER
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PCA PUMP HAD BEEN LOADED. WHEN THE NURSE ATTEMPTED TO PROGRAM THE PUMP, SHE HAD TO LOCK AND UNLOCK THE DOOR. THE DOOR/LOCK THEN GOT STUCK. SHE WAS UNABLE TO PROGRAM PUMP OR OPEN THE DOOR OF THE PUMP TO RETRIEVE THE MEDICATION. DOOR HAD TO BE FORCED OPEN TO RETRIEVE MEDICATION. THE PUMP WAS UNPROGRAMMABLE. PUMP WAS TAKEN OUT OF SERVICE AND SENT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36299 BAXTER PCA II PUMP, INFUSION, PCA MEA BAXTER 03782943 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR