BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4181082 · Received September 24, 2014

    Report

    Report Number
    9616066-2014-00955
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    February 21, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER'S MEDWATCH STATES "THE SECONDARY BAG OF IV FLUIDS CONTAINING AN ANTIBIOTIC WAS HUNG. THE TUBING WAS PRIMED USING THE PRIMARY IV FLUIDS BAG. THE SECONDARY BAG WAS OPENED AND BEGAN FLOWING, THERE WERE AIR BUBBLES IN THE PRIMARY TUBING (WHEN THE PUMP WAS STARTED)." ALTHOUGH REQUESTED, NO FURTHER INFO WAS PROVIDED, NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592999 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PCU: SN UNK| ALARIS PUMP MODULE: SN UNK