BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE MODEL 4P PUMP NO I/O

    MDR report key: 305966 · Received November 17, 2000

    Report

    Report Number
    2921482-2000-00254
    Event Type
    Malfunction
    Date Received
    November 17, 2000
    Date of Event
    October 1, 2000
    Report Date
    October 24, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF AN UNDER-DELIVERY DURING ROUTINE TESTING. THIS PUMP IS ONE OF TWO PUMPS THAT WAS REPORTED TO UNDER-DELIVER FOR AN ABBOTT FIELD SERVICE REP. THE CUSTOMER CONTACT REPORTED THAT THEY DECLINED TO RETURN THE PUMP FOR REPAIR AT THIS TIME. THE CUSTOMER REPORTS THAT THE PUMP IS "YELLOW TAGGED" DO NOT USE AND IS SITTING ON A SHELF AND WILL NOT BE RETURNED TO CLINICAL SERVICE. THERE IS NO REPORTED ADVERSE PT EVENT WHILE THE PUMP WAS IN CLINICAL SERVICE. THOUGH REQUESTED, THERE WAS NO FURTHER INFO AVAILABLE.

    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