BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP

    MDR report key: 365707 · Received December 10, 2001

    Report

    Report Number
    2921482-2001-00484
    Event Type
    Malfunction
    Date Received
    December 10, 2001
    Date of Event
    October 22, 2001
    Report Date
    November 7, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED THAT THE PUMP WOULD NOT DELIVER THE CONTINUOUS RATE WHEN PROGRAMMED FOR CONTINUOUS PLUS BOLUS DELIVERY. THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE WITH THE FOLLOWING SETTINGS: CONCENTRATION 5MG/ML, 1MG/H CONTINUOUS RATE, 1MG BOLUS EVERY 10 MINUTES, AND 6 BOLUSES/H. NO REPORT OF ANY PT ADVERSE EFFECTS. THOUGH REQUESTED, NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55403 ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other