BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORENSON MEDICAL PCA PUMP

    MDR report key: 1582415 · Received January 14, 2010

    Report

    Report Number
    MW5014383
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    January 14, 2010
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PCA PUMP WAS USED FOR LABOR EPIDURAL, DELIVERY IMPAIRED WHEN MEDICATION BAG CHANGED AND NOT APPROPRIATELY RESTARTED; HOWEVER, THE PUMP APPEARED TO BE PUMPING BUT NOT DELIVERING THE MEDICATION. SALES REPRESENTATIVE (B) (4) MET WITH SPOUSE, ANESTHESIA, PT ADVOCATE AND OTHERS TO DISCUSS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORENSON MEDICAL PCA PUMP PCA PUMP MEA SORENSON MEDICAL, INC. 0

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other