BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 96407 · Received May 30, 1997

    Report

    Report Number
    6000001-1997-00688
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    May 1, 1997
    Report Date
    May 1, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFUSION PUMP WAS INVOLVED IN AN OVERDELIVERY OF A NTG SOLUTION. REPORTEDLY THE PUMP WAS PROGRAMMED TO DELIVER 50 ML HOWEVER IT DELIVERED 500 ML. THE INFUSION RATE WAS NOT REPORTED. IT WAS COMMENTED THAT THE PT WAS INITIALLY HYPOTENSIVE, HOWEVER, NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THE PT RETURNED TO PRE-INCIDENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 6201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN