BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PLUM A + INFUSION PUMP

    MDR report key: 537833 · Received March 22, 2004

    Report

    Report Number
    2921482-2004-00166
    Event Type
    Malfunction
    Date Received
    March 22, 2004
    Date of Event
    March 4, 2004
    Report Date
    March 5, 2004
    Manufacturer
    ABBOTT LABS
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF THE DEVICE FAILING TO DETECT DISTAL AIR IN LINE. DURING TESTING AT THE USER FACILITY, THE PUMP FAILED TO DETECT DISTAL AIR IN LINE. THERE WERE NO REPORTS OF ANY PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PLUM A + INFUSION PUMP INFUSION PUMP FRN ABBOTT LABS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other