BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA INFUSION PUMP

    MDR report key: 1864695 · Received October 1, 2010

    Report

    Report Number
    1864695
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 1, 2010
    Manufacturer
    HOSPIRA
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING PCA PAIN CONTROL WHEN THE PCA STARTED TO ALARM A HIGH PITCHED ALARM, SCREEN READ "MALFUNCTION 635/0018" AND "PLEASE TURN OFF AND SEND FOR SERVICE." PATIENT WAS WITHOUT PAIN MANAGEMENT FOR ABOUT 20 MINS WHILE WE WAITED FOR ANOTHER PCA TO ARRIVE TO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA INFUSION PUMP PCA INFUSION PUMP MEA HOSPIRA LIFECARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR