BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 123723 · Received September 26, 1997

    Report

    Report Number
    6000001-1997-00994
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    August 22, 1997
    Report Date
    August 29, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PUMP REPORTED TO OVERINFUSE AMINOPBLY LINE USING PUMP 1. THE PUMP WAS SET TO DELIVER AT A RATE OF 35 ML/HR WITH A 500 ML BAG. THE ENTIRE BAG DELIVERED IN 2 HRS. NO ADVERSE PT OUTCOME. BLOOD WORK SHOWED HIGHER LEVELS OF AMINOPHYLINE, BUT NO MEDICAL INTERVENTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN