BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PLUM PUMP MODEL 5000

    MDR report key: 201371 · Received December 8, 1998

    Report

    Report Number
    2921482-1998-00196
    Event Type
    Malfunction
    Date Received
    December 8, 1998
    Date of Event
    September 19, 1998
    Report Date
    November 3, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OVERDELIVERY REPORTED. THE PUMP HAD BEEN SET UP IN THE CONCURRENT MODE TO RUN NORMAL SALINE AT 100ML/H VIA PRIMARY WITH A SECONDARY INFUSION OF AN UNSPECIFIED AMOUNT OF AZIDO-THYMIDINE IN 280ML TOTAL SOLUTION TO RUN AT 26ML/H. THE SECONDARY SOLUTION WAS REPORTEDLY STARTED AT 11:15AM, AND AT 2:15PM A NURSE REPORTS THAT INSTEAD OF THE EXPECTED 78ML THE DEVICE HAD INFUSED 156ML. THE DISPLAY WAS CHECKED AND THE PUMP REPORTEDLY WAS SET CORRECTLY; HOWEVER, THE SECONDARY VOLUME INFUSED REGISTERED 156ML. THE PUMP WAS SWITCHED OUT. THERE WERE NO ADVERSE EFFECTS REPORTED FOR THE PT OR FETUS. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PLUM PUMP MODEL 5000 INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other