BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE IV PUMP

    MDR report key: 22420 · Received June 13, 1995

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    Report

    Report Number
    MW1006219
    Event Type
    Injury
    Date Received
    June 13, 1995
    Date of Event
    May 25, 1995
    Report Date
    June 2, 1995
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IV TUBING FROM PUMP CASSETTE WAS DETACHED. PT BEGAN TO BLEED. DEVICE WAS RETAINED FOR INVESTIGATION AND BIOMED DEPT WAS NOTIFIED. THE MEDICAL SAFETY DEVICE AD HOC COMMITTEE MET TO RENEW THE INCIDENT. TUBING FROM PT TO PUMP REMAINED ATTACHED, THUS NO PUMP ALARM. THE TUBING IS PERMANENTLY ATTACHED AT POINT OF MFR AND SHOULD NOT DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE IV PUMP IV PUMP FRN ABBOTT LABORATORIES 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention