BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL MICRO/MACRO PUMP

    MDR report key: 534724 · Received March 15, 2004

    Report

    Report Number
    2921482-2004-00142
    Event Type
    Malfunction
    Date Received
    March 15, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 17, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF NO AUDIBLE ALARM. THE PUMP WAS UNDERGOING PREVENTATIVE MAINTENANCE TESTING IN THE BIOMEDICAL ENGINEERING DEPARTMENT AND WAS FOUND TO HAVE NO AUDIBLE ALARM WHEN THE ALARM WAS SET AT ITS LOWEST SETTING. THE CUSTOMER INDICATED THEY HAVE NO KNOWLEDGE OF THE PUMP HAVING BEEN IN PT USE WHILE THE ALARM WAS AT ITS LOWEST SETTING. THOUGH REQUESTED, NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL MICRO/MACRO PUMP INFUSION PUMP KZD ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other