BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2161372 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11766
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 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 REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A BROKEN ALTERNATING CURRENT (AC)POWER CORD WAS CONFIRMED DURING EVALUATION. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A CRACKED/BROKEN AC POWER CORD. THE AC POWER CORD WAS REPLACED TO FIX THE REPORTED CONDITION. THE SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF A BROKEN ALTERNATING CURRENT POWER CORD. 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 (B)(4)). 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

    DURING BAXTER'S REVIEW OF A FLOGARD FOR ANOTHER REPORT, IT WAS DISCOVERED THAT THERE WAS A BROKEN ALTERNATING CURRENT POWER CORD. THE EVENT OCCURRED DURING POWER ON. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. 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