BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA LIFECARE PCA

    MDR report key: 1843443 · Received September 21, 2010

    Report

    Report Number
    MW5017534
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    May 5, 2010
    Report Date
    September 21, 2010
    Manufacturer
    HOSPIRA WORLDWIDE, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PERSON FROM OUTSIDE OUR HOSPITAL ENTERED PATIENT ROOMS WHO HAD PATIENT CONTROLLED ANALGESIA -PCA- PUMPS, HAD HER OWN KEY FROM THE PLACE OF HER PREVIOUS EMPLOYMENT, WAS ABLE TO ENTER THE PUMP AND TAKE OUT THE NARCOTIC. THIS WAS THE FIRST WE KNEW THAT THE PCA PUMP KEYS WERE UNIVERSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA LIFECARE PCA PATIENT CONTROLLED ANALGESIA PUMP MEA HOSPIRA WORLDWIDE, INC. 20709-04-77 20709-04-77

    Patients

    Seq Age Sex Outcome Treatment
    1 Other