BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO)

    MDR report key: 15364750 · Received September 6, 2022

    Report

    Report Number
    1221934-2022-02646
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705017393
    PMA / PMN Number
    K951843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. UPON VISUAL INSPECTION, IT WAS FOUND A DAMAGE FOUND NEAR THE CHAMBER BRACKET, THE TUBING WAS CRACKED; THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3001136, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE POSSIBLE ROOT CAUSE COULD BE RELATED WHEN THE TUBE IS NOT SEATED CORRECTLY ON THE CHAMBER BRACKET. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. AS PER IFU, WHEN PLACING THE FILL CHAMBER IN THE BRACKET, MAKE SURE THAT THE FILL CHAMBER SYMBOL IS FACING TOWARD THE USER AND TUBING IS NOT TWISTED. IMPROPER POSITIONING COULD CAUSE THE TUBE TO TWIST AND OBSTRUCT THE FLOW OF FLUID. DO NOT INVERT FILL CHAMBER AT ANY TIME. TO PRIME THE PUMP, PRESS AND HOLD THE FILL CHAMBER PAD UNTIL THE CHAMBER IS 1/3FULL. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405266 FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE HRX DEPUY MITEK LLC US 284504 3001136 10886705017393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown