BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PUMP MODEL 4P W/IO

    MDR report key: 140515 · Received December 23, 1997

    Report

    Report Number
    2921482-1997-90010
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    December 5, 1997
    Report Date
    December 5, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UNDERDELIVERY NOTED DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY BIOMEDICAL ENGINEERING. THE PUMP WAS REPORTEDLY TESTED USING ABBOTT PERFORMANCE VERIFICATION TESTING PROCEDURES. EXPECTED DELIVERED AMOUNTS WERE 20ML, THE DEVICE CONSISTENTLY DELIVERED 14-15ML. NO PT INVOLVEMENT. NO REPORTS OF ANY PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PUMP MODEL 4P W/IO INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other