BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1232100 · Received November 7, 2008

    Report

    Report Number
    6000001-2008-00733
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS SCHEDULED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FEMALE PATIENT WAS RECEIVING INFED IVPB BY A FLO-GARD VOLUMETRIC INFUSION PUMP VIA AN UNKNOWN SET. DURING AN UNSPECIFIED TIME PERIOD, AFTER ADMINISTRATION BEGAN, PUMP ALARMED "LOW VOLUME". NURSE ENTERED PATIENT'S ROOM AND FOUND SOLUTION BAG AND TUBING SET EMPTY, BUT PUMP CONTINUED TO PUMP AT A KEEP VEIN OPEN (KVO) RATE. AIR WAS NOTED IN TUBING. AIR IN LINE ALARM WAS NOT SOUNDING. NURSE DISCONTINUED INFUSION IMMEDIATELY AND DISCONNECTED THE SET FROM PATIENT. THE UNKNOWN SET WAS DISCARDED. CUSTOMER REPORTED PATIENT WAS NOT INJURED AND DID NOT SUFFER ANY SYMPTOMS OR ADVERSE EFFECTS FROM THE INCIDENT. THE PUMP WAS RETURNED TO BAXTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG)

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR