BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUID MANAGER SYSTEM

    MDR report key: 1490636 · Received September 21, 2009

    Report

    Report Number
    1418479-2009-00012
    Event Type
    Injury
    Date Received
    September 21, 2009
    Date of Event
    August 18, 2009
    Report Date
    September 21, 2009
    Manufacturer
    W.O.M. (WORLD OF MEDICINE AG)
    Product Code
    HIG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL. THERE ARE TWO DIFFERENT COMPONENTS THAT MAKE UP THE FLUID MANAGER SYSTEM AND EACH COMPONENT HAS THE SAME SERIAL #. THERE IS THE (B)(4) FLUID MANAGER PUMP AND THE (B)(4) FLUID MANAGER SCALE/STAND. BOTH OF THESE COMPONENTS TOGETHER MAKE THE COMPLETE INSTRUMENT OF (B)(4) - FLUID MANAGER SYSTEM. EVALUATION SUMMARY - (B)(4) - FLUID MANAGER SYSTEM - (B)(4). THE FLUID MANAGER SYSTEM WAS FUNCTIONALLY TESTED WITHIN (B)(6) MEDICAL FACILITY (B)(6) 2009. THE BIO-MEDICAL ENGINEER FROM THE END USER FACILITY BROUGHT THE UNIT TO OUR FACILITY AND WAS PRESENT FOR THE TEST AND RECALIBRATION DEMONSTRATION. THE UNIT WAS FOUND TO BE WITHIN OPERATIONAL SPECIFICATIONS AND WAS IN FINE OPERATIONAL CONDITION. THERE WERE NO ADJUSTMENTS REQUIRED. THE UNIT WAS RELEASED TO THE CUSTOMER. CAUSE: NO CONCLUSION CAN BE DRAWN. IT IS UNLIKELY THAT THE FLUID MANAGER CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AT THE BEGINNING 1228 OF A HYSTEROSCOPY PROCEDURE TO RESECT LARGE FIBROIDS, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION. IT WAS REPORTED THAT THE FLUID MANAGER SHOWED A DEFICIT OF 2500 ML. THE PROCEDURE WAS STOPPED AT 1500 AND TAKEN TO PACU FOR CARDIOLOGY CONSULT. THE PATIENT WAS SENT TO ICU FOR THE NIGHT AND GIVEN DIURETICS WITH 2700 OF OUTPUT. THE PATIENT WAS DISCHARGED (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID MANAGER SYSTEM FLUID MANAGER SYSTEM HIG W.O.M. (WORLD OF MEDICINE AG) 2222.223

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization