BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 115398 · Received August 22, 1997

    Report

    Report Number
    6000001-1997-00945
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 25, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE, LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION PUMP WAS INVOLVED IN AN OVERINFUSION OF A NTG SOLUTION. REPORTEDLY THE PUMP WAS PROGRAMMED TO DELIVER AT 3 ML/HR, HOWEVER THE 250 ML SOLUTION CONTAINER INFUSED IN ONLY ONE HOUR. THERE WAS NO ADVERSE PT OUTCOME AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE, LTD. 6301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN