BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3854015 · Received May 16, 2014

    Report

    Report Number
    2016493-2014-00246
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    February 14, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER'S MEDWATCH STATES "IV PUMP WAS SET TO INFUSE D12.5% AT 8 ML. BAG VOLUME OF 250 ML WAS INITIALLY HUNG AT 22:50 AT 14:00 THE NEXT DAY, GLUCOSE WAS 70 MG/DL. AT 18:00, THE PUMP ALARMED 'AIR IN LINE' AND THE IV BAG WAS NOTED TO BE UNEXPECTEDLY EMPTY, INCONSISTENT WITH THE SET RATE. RN REMOVED THE IV TUBING FROM THE INFANT, AND BEDSIDE GLUCOSE CHECKED TO BE 499 MG/DL, BUT RETURNED TO NORMAL WITHIN 75 MINUTES. AT THAT TIME, IV FLUIDS WERE RESTARTED AT THE ORDERED RATE OF 8 ML/HR. GLUCOSE LEVELS REMAINED STABLE. INFANT EXAM WAS BENIGN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294626 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other ALARIS PUMP MODULE ADMINISTRATION SET,| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| MODEL/LOT #UNK| ALARIS PC UNIT, SN UNK