BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFUSE PUMP

    MDR report key: 230226 · Received July 2, 1999

    Report

    Report Number
    9614448-1999-00001
    Event Type
    Malfunction
    Date Received
    July 2, 1999
    Date of Event
    May 20, 1999
    Report Date
    May 20, 1999
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REVIEWED THE INFUSION HISTORY OF THE PT'S AMBULATORY PT CONTROLLED ANALGESIA PUMP. THE VOLUME OF DRUG DELIVERED HAD EXCEEDED THE VOLUME LIMIT PROGRAMMED IN TO THE DEVICE. PT EXPERIENCED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFUSE PUMP AMBULATORY INFUSION PUMP FRN DISETRONIC MEDICAL SYSTEMS AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other