BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP ADMIN SET

    MDR report key: 3150137 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00335
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    RECEIVED FROM FDA A COPY OF CUSTOMER MEDSUN REPORT. EVENT DESC: "ANESTHESIA TRIED TO PUSH MEDS WITH BLUNT NEEDLE THROUGH EXTENSION TUBING AND THE RUBBER PORT BUSTED THROUGH AND LEAKED EVERYWHERE. NEW LINE HAD TO BE SPIKED AND HUNG AND 19 INCH GAUGE NEEDLE USED TO SPIKE PORT." THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFORMATION PROVIDED BY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189390 ALARIS SE PUMP ADMIN SET FPA CAREFUSION CORPORATION 11501183 12116062

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR SE INFUSION PUMP, MODEL AND SN UNK| EXTENSION SET, MFR/MODEL/LOT # UNK