BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2173570 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13608
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 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 NOT DISPENSING WAS NOT CONFIRMED NOR DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED AND NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER.

    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 "DAMAGE, 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 INTENSIVE CARE UNIT. 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