BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2173526 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13606
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP THAT WILL NOT DISPENSE WAS NOT CONFIRMED DURING PRODUCT EVALUATION. THE QUALITY ENGINEER ASSIGNED THE BROKEN DOOR TO BE THE AS DETERMINED PROBLEM CODE. THIS DETERMINED CONDITION WAS CAUSED BY A BROKEN HINGE STOP DUE TO MISHANDLING. THE PUMP HEAD DOOR WAS REPLACED TO CORRECT THE REPORTED CONDITION. 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 DECEMBER 31ST, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH A MALFUNCTION OF "INFUSION NOT LOWER." AFTER FURTHER INVESTIGATION, THE FACILITY LATER CLARIFIED THAT THE MALFUNCTION OF THE DEVICE WAS THAT THE "EQUIPMENT WILL NOT DISPENSE." THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP IN THE EMERGENCY ROOM DEPARTMENT. THE HOSPITAL REPRESENTATIVE DID NOT HAVE ANY INFORMATION ON PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1