BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PC1 INFUSION PUMP

    MDR report key: 2221945 · Received August 17, 2011

    Report

    Report Number
    2016493-2011-00461
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K880479
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE 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

    THE USER REPORTED THAT A 100 ML INFUSION WAS SET TO RUN AT 35ML/HOUR, HOWEVER AN HOUR AND 50 MINS INTO THE INFUSION THE CONTAINER WAS EMPTY WITH NO EVIDENCE OF LEAKAGE. THE VOLUME TO BE INFUSED (VTBI) ON THE PUMP WAS STILL SHOWING 48ML AT THIS POINT. 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 GEMINI PC1 INFUSION PUMP FRN CAREFUSION CORP 1311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMINI ADMINISTRATION SET: MODEL/LOT UNK