BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+3 MULTICHANNEL INFUSION PUMP

    MDR report key: 442285 · Received February 4, 2003

    Report

    Report Number
    2921482-2003-00053
    Event Type
    Malfunction
    Date Received
    February 4, 2003
    Date of Event
    December 24, 2002
    Report Date
    January 14, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A POSSIBLE OVER-DELIVERY. THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PENTOBARBITAL AT A TITRATED RATE DEPENDENT ON THE PT'S EEG. DURING THE SHIFT CHANGE, THE NURSE NOTED THAT THERE WAS A 64ML DISCREPANCY BETWEEN WHAT WAS DOCUMENTED ON THE MEDICATION SHEET VERSUS THE AMOUNT OF SOLUTION REMAINING IN THE CONTAINER. THERE WAS NO REPORTED ADVERSE PT EFFECT. THOUGH REQUESTED, NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 MULTICHANNEL INFUSION PUMP INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other