BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL3M MICRO/MACRO PUMP

    MDR report key: 529018 · Received February 27, 2004

    Report

    Report Number
    2921482-2004-00103
    Event Type
    Malfunction
    Date Received
    February 27, 2004
    Date of Event
    January 30, 2004
    Report Date
    February 4, 2004
    Manufacturer
    ABBOTT LABS
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN OVERDELIVERY. DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITIY, THE DEVICE OVERDELIVERED AN UNSPECIFIC AMOUNT ON CHANNEL B. THE CUSTOMER CONTACT COULD NOT PROVIDE ANY SPECIFIC TESTING PARAMETERS. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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 PLUM XL3M MICRO/MACRO PUMP INFUSION PUMP FRN ABBOTT LABS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other