BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 334384 · Received May 18, 2001

    Report

    Report Number
    MW1021938
    Event Type
    Malfunction
    Date Received
    May 18, 2001
    Date of Event
    March 16, 2001
    Report Date
    May 4, 2001
    Manufacturer
    BIOTECT INSTRUMENTS ALARIS MEDICAL SYSTEMS, INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS GIVEN PACKAGED RED BLOOD CELLS WITH A BEGINNING VOLUME TO BE INFUSED OF 275 CC. THE MED GEMINI-PC-1 PUMP (95985) APPREARED TO BE FUNCTIONING NORMALLY. WHEN THE PRBC SHOULD HAVE BEEN ALMOST DONE (VTBI DISPLAYED 30CC).THE BAG WAS FOUND TO BE ALMOST FULL OF BLOOD. THE TUBING WAS CLAMPED BETWEEN THE PUMP AND THE PT. THE PUMP APPEARED TO BE STILL RUNNING WITHOUT ALARMING. COMPLAINT: INFUSION PUMP DID NOT DELIVER MEDICATION AND DID NOT GIVE AN OCCLUSION ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23663 ALARIS PC-1 PUMP FRN BIOTECT INSTRUMENTS ALARIS MEDICAL SYSTEMS, INC PC-1 / ID A4 95985 (TD1#)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other NONE AVAILABLE