BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 9483944 · Received December 17, 2019

    Report

    Report Number
    0001954182-2019-00083
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 5, 2019
    Report Date
    January 16, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K133786
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DHR REVIEW: 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. EVALUATION OF DEVICE: ON 5 NOVEMBER 2019, A ZIMMER BIOMET AUTHORIZED REPAIR TECHNICIAN WAS CONTACTED ABOUT THE CART AND DISPATCHED TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND CONFIRMED THAT THE CART WAS GIVING LEVEL SENSOR RANGE ERRORS FOR BOTH CYLINDERS. THE TECHNICIAN REPLACED THE LEVEL SENSORS FOR EACH CYLINDER (PART #91584 AND LOT # 0026756, 0025972) AND FOUND THAT THE ISSUE PERSISTED. THE TECHNICIAN THEN REPLACED THE UNIT CONTROL BOARD (PART #91940 AND LOT #0040943) AND THEN VERIFIED THAT THE UNIT WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE UNIT TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. PROBABLE/ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED EVENT THAT THE UNIT WAS ISSUING LEVEL SENSOR RANGE ERRORS WAS DUE TO A DEFECTIVE CONTROL BOARD. THE CONTROL BOARD DESIGNATES THE FLOW OF ELECTRIC CURRENT TO THE DESIGNATED COMPONENTS, SUCH AS THE LEVEL SENSOR. THE LEVEL SENSOR MEASURES THE VOLUME OF FLUID IN THE CYLINDER, AND WHEN DEFECTIVE CAN PROVIDE THE INCORRECT OR NO OUTPUT. A DEFECTIVE CONTROL BOARD PREVENTS THE FLOW OF CURRENT TO THE LEVEL SENSOR, AND THEREFORE PREVENTS THE UNIT FROM REPORTING THE CORRECT FLUID LEVELS. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CONTROL BOARD AND LEVEL SENSORS WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED. COMPLAINT TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. EVALUATED BY EXTERNAL CONTRACTOR.

    Description of Event or Problem · 1

    DURING CLEANING IT WAS REPORTED THAT THE CART WAS GIVING LEVEL SENSOR ERRORS FOR BOTH CYLINDERS, AS WELL AS DISPLAYING INCORRECT INFORMATION FOR FLUID VOLUME IN BOTH CYLINDERS. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277822 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0020103

    Patients

    Seq Age Sex Outcome Treatment
    1