BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3042428 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00173
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 14, 2012
    Report Date
    February 18, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH CUSTOMER MEDWATCH STATED THE DEVICE WAS RETURNED ON (B)(4) 2013, 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

    RECEIVED COPY OF CUSTOMER'S MEDWATCH WHICH STATES "PT HAS A PICC LINE INSERTED TO LEFT CHEST AREA...CUBICIN WAS HUNG AND HAD INFUSED ABOUT 6 MINUTES AND... THE PT'S SHIRT WAS WET. THE TUBING HAD BROKEN FROM END, LEAVING THE PT'S LINE OPEN AND BLEEDING. THE PORT WAS CLAMPED AND CUBICIN STOPPED. PHARMACY WAS NOTIFIED FOR NEW BAG OF CUBICIN... PT WAS NOT HURT." NO FURTHER PT/EVENT INFO IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106261 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

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