BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ PUMP SET

    MDR report key: 1061879 · Received June 13, 2008

    Report

    Report Number
    9615050-2008-00164
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 29, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE TUBING SET WAS RETURNED FROM AN UNSPECIFIED DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "K+ PIGGYBACK BAG BACKED UP INTO MAIN IV OR NORMAL SALINE." NO TRACKING INFO WAS PROVIDED; THEREFORE, NO SPECIFIC PT INFO OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTED ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ PUMP SET 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK