BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 7759873 · Received August 7, 2018

    Report

    Report Number
    0001954182-2018-00053
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 8, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PMA #: K081047; K123188; K133786. THE DEVICE IS IN PROCESS OF BEING EVALUATED BY AN EXTERNAL CONTRACTOR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PREVIOUS REPAIR REPORT FOR ULTRA DUO FLEX FLUID CART SERIAL NUMBER (B)(4), WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. USING CRM TO QUERY FOR SERIAL NUMBER 160306, THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED THREE TIMES, THE PREVIOUS REPAIR BEING FOR A MANIFOLD HOUSING ISSUE ON 27 MARCH 2018. THE MANIFOLD HOUSING ISSUE WAS NOT ASSOCIATED WITH THE CURRENT REPORTED ISSUE, SO THE PREVIOUS REPAIR WAS A NON-RELATED ISSUE. ON 12 JULY 2018, IT WAS REPORTED BY ORO VALLEY HOSPITAL THAT THE UNIT WAS NOT CONNECTING WITH THE EVAC AND ALSO ADDED THAT THE UNIT WAS NOT READING FLUID LEVEL PROPERLY. ARIZONA BIOMEDICAL SERVICES WAS CONTACTED ABOUT THE ISSUE AND SERVICE TECHNICIAN WAS DISPATCHED TO THE SITE. ON 13 JULY 2018, THE TECHNICIAN CONFIRMED THAT THE UNIT WAS NOT READING FLUID LEVEL AND NOT MAKING CONNECTION WITH EVAC. HE REPLACED RECEIVER WITH RECEIVER ELECTRONICS KIT AS WELL AS THE LEVEL SENSOR IN BOTH CYLINDERS WITH DUO QUAD LEVEL SENSOR SERVICE KIT. UPON TESTING UNIT FOR PERFORMANCE , HE FOUND THAT THE UNIT WASN'T DISPLAYING FLUID LEVEL VALUE IN DIGITAL FORMAT, BUT CONFIRMED THAT THE LEVEL SENSOR WAS READING CORRECT FLUID LEVELS WITH ANALOG FORMAT. ON 18 JULY 2018, HE REPLACED BOTH THE DISPLAY WITH A REFURBISHED ULTRA CART DISPLAY KIT V4.3 AND THE CONTROL BOARD WITH DUO CONTROL BOARD KIT. HE THEN VERIFIED THAT THE UNIT WAS FUNCTIONING AS INTENDED AND RETURN THE UNIT TO SERVICE. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. BASED ON THE INFORMATION, THE ROOT CAUSE OF THE COMMUNICATION ISSUE WAS DUE TO A MALFUNCTIONED RECEIVER; WHICH PREVENT THE CART FROM ESTABLISHING PROPER ELECTRICAL AND DATA TRANSFERABLE CONNECTION WITH THE EVAC. WHEN THERE WAS NO PROPER CONNECTION WAS ESTABLISHED, THE UNIT WILL TRIGGER EVAC COMM ERROR TO THE CART. ALSO, THE ROOT CAUSE OF THE REPORTED UNIT NOT REGISTERING FLUID LEVELS WAS DUE TO A MALFUNCTIONING LEVEL SENSOR; WHICH MAKES THE LEVEL SENSOR TO READ FLUID INACCURATE FLUID LEVELS. BOTH CONNECTION ISSUE AND INCORRECT FLUID LEVEL ISSUE WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE LEVEL SENSOR AND RECEIVER WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS NOT CONNECTING TO EVAC. IT WAS ALSO REPORTED THAT THE UNIT DOES NOT REGISTER FLUID PROPERLY ON BOTH CYLINDERS. THE DEVICE HAD A BAD LEVEL SENSOR. THE EVENT OCCURRED DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598996 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0024179

    Patients

    Seq Age Sex Outcome Treatment
    1