BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM V/NV CKV 2YS 20DP 20PK

    MDR report key: 270911 · Received March 21, 2000

    Report

    Report Number
    9680801-2000-00001
    Event Type
    Death
    Date Received
    March 21, 2000
    Date of Event
    February 3, 2000
    Report Date
    February 24, 2000
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SET PUMPING CHAMBER BALLOONED AND CAUSED PUMP TO GO INTO PT. SIDE OCCLUSION ALARM CONDITION WITH RESULTANT DEVICE SHUT DOWN. PT EXPIRED. RN STATED NOT SURE IF PT'S REAL TIME CONDITION (RESPIRATORY DISTRESS) OR THE DELAY IN MEDICATION CAUSED BY THE INFUSION PUMP DEVICE SHUT DOWN WITH VISUAL AND AUDIBLE ALARMS CONTRIBUTED TO THE PT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM V/NV CKV 2YS 20DP 20PK INFUSION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2220-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death