BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2221946 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00456
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE IV LINE WAS PRIMED WITH SALINE, THEN A BLOOD INFUSION WAS CONNECTED TO ONE OF THE TWO SPIKES AND SET TO RUN OVER 4 HOURS. FOUR HOURS AFTER THE COMMENCEMENT OF THE TRANSFUSION, THE PUMP HAD ONLY INFUSED HALF OF THE BAG OF BLOOD. ON CLOSER INSPECTION, IT WAS NOTED THAT THE SALINE FROM THE SECOND SPIKE WAS DRIPPING IN THE DRIP CHAMBER DESPITE THE CLAMP BEING ON. THEY ALSO NOTICED THAT THE SALINE WAS BEING DRAWN INTO THE BLOOD BAG. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2477-0000 UNK

    Patients

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