BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2161413 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11782
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 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). THE CONDITION FOR A FLO-GARD INFUSION PUMP IN WHICH "MARK AIR" WAS REPORTED WAS NOT CONFIRMED AND NOT DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THIS CONDITION AND NO REPAIR WAS NECESSARY. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR 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 (REFER TO END OF SERVICE NOTIFICATION 410695). BAXTER CONTINUES TO SUPPORT THE PRODUCT IN THE LATIN AMERICA REGION AND WILL DO SO UNTIL PARTS REMAIN AVAILABLE. PER THE FLO-GARD QUALITY PLAN ((B)(4)) 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. HOWEVER, BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY (DSI) EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES (E.G., HHA, MDR, FCA ETC.) TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A FLOGARD IN WHICH "MARK AIR" OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THE EVENT OCCURRED DURING PROGRAMMING/SET-UP IN THE INTENSIVE CARE UNIT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED REPORTED. THERE IS NO FURTHER COMPLAINT INFORMATION 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