BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMED PC-1

    MDR report key: 393547 · Received May 13, 2002

    Report

    Report Number
    393547
    Event Type
    Injury
    Date Received
    May 13, 2002
    Date of Event
    April 23, 2002
    Report Date
    May 8, 2002
    Manufacturer
    ALARIS MEDICAL SYSTEM
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATUS POST SPONTANEOUS VAGINAL DELIVERY AT 34 WEEKS WITH PRE-ECLAMPSIA. TRANSFERRED TO MBU ON MG504 2 GM/HR VIA IMED. APPROX 211CC REMAINED IN BAG-INFUSING AT 20 CC/HR. PT UP TO BREAST FEED AND PT WITH SUDDEN FLUSHING; THEN LOSS OF CONSCIOUSNESS WITH FULL CODE. RESUSCITATED AND TRANSFERRED TO NEURO ICU. IMED FOUND WITH DOOR AJAR AND TUBING DISPLACED BAG EMPTY. PT'S FRIEND STATES THEY OPENED DOOR TO STOP PUMP FROM BEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED PC-1 INFUSION PUMP FRN ALARIS MEDICAL SYSTEM PC-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R