BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1820447 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02875
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 3 WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE CHANNEL 1 AND 2 DOOR ASSEMBLIES BEING BROKEN IN THEIR LATCH AREAS. THE CHANNEL 1 AND 2 DOOR ASSEMBLIES WERE REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH FAILURE CODE 3, WHICH IS A DOWNSTREAM OCCLUSION FAILURE CODE. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS FACILITY WAS NOT WILLING TO BE CONTACTED FOR ANY FURTHER INFORMATION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. DURING PRODUCT EVALUATION, FAILURE CODE 3 WAS CONFIRMED TO BE CAUSED BY THE CHANNEL 1 AND 2 DOOR ASSEMBLIES BEING BROKEN IN THEIR LATCH AREAS, INDICATING FAILURE CODE 3 WAS A FALSE OCCLUSION ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1