BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 2003957 · Received March 1, 2011

    Report

    Report Number
    6000001-2011-01455
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    September 12, 2010
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2 WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE DOWNSTREAM OCCLUSION CALIBRATION BEING OUT OF SPECIFICATION. THE CUSTOMER REFUSED THE SERVICE ESTIMATE; THEREFORE, NO REPAIRS WERE MADE TO THE DEVICE AND THE DEVICE WAS RETURNED TO THE CUSTOMER UNREPAIRED AND UNVERIFIED. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD 2M8063 (6201) AND 2M8064 (6301) IN THE U.S. REGION AS OF (B)(4) 2010. BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS, BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS FOR PRODUCT IMPROVEMENTS WILL NO LONGER BE REQUIRED. BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED F2 NINE TIMES ON THE REPORTED OCCURENCE DATE. DURING DEVICE EVALUATION, THE UPPER HINGE STOP, LOWER HINGE STOP AND LATCH STOP WERE FOUND BROKEN ON THE DOOR OF THIS DEVICE, INDICATING THAT THESE OCCURENCES OF F2 REPRESENT FALSE OCCLUSION ALARMS. THERE WAS NO PATIENT INVOLVEMENT. 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