BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3802887 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00444
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CAREFUSION CORPROATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE PRODUCT BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE DISPOSABLE SET, COMING FORM THE SMARTSITE PORT JUST BELOW THE PUMP MODULE, DURING A HEPARIN INFUSION. THE PATIENT NOTICED A DRIP GO DOWN THE TUBING AND NOTIFIED THE NURSE. THE BLUE SMARTSITE PISTON WAS NOTED TO BE DISLODGED FROM THE TOP OF THE SMARTSITE BODY. THE LEAK WAS DISCOVERED WITHIN 24-48 HOURS OF HANGING THE IV SET AND HEPARIN BAG. REPORTEDLY NOTHING WAS PIGGYBACKED OR INJECTED INTO THE PORT PRIOR TO THE LEAK BEING NOTICED. THE CUSTOMER REPORTED THAT ADDITIONAL BLOOD WORK WAS DRAWN, AND ADDITIONAL HEPARIN BOLUSES AND INCREASED RATE WERE PERFORMED DUE TO THE LEAKING. THE SET WAS CHANGED OUT, AND AT THE NEXT BLOOD DRAW THE PATIENT'S BLOOD LEVEL WAS BECOMING THERAPEUTIC. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258139 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPROATION 2426-0007 UNK

    Patients

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