BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE MODEL 4P PUMP NO I/O

    MDR report key: 221161 · Received April 26, 1999

    Report

    Report Number
    2921482-1999-00070
    Event Type
    Malfunction
    Date Received
    April 26, 1999
    Date of Event
    March 22, 1999
    Report Date
    March 22, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PUMP REPORTEDLY FAILED ROUTINE BIOMEDICAL ENGINEERING DELIVERY ACCURACY TEST PROCEDURES. WITH AN EXPECTED DELIVERY OF 19-21 ML, THE PUMP REPORTEDLY DELIVERED ONLY 15-16ML. THERE WERE NO REPORTS OF ANY PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THIS WAS NOTED DURING ROUTINE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE MODEL 4P PUMP NO I/O INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other