BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7946620 · Received October 9, 2018

    Report

    Report Number
    0001954182-2018-00064
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    July 18, 2018
    Report Date
    October 9, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA 510(K): K081047; K123188; K133786. THE DEVICE HISTORY RECORD (DHR) FOR ULTRA DUO FLEX FLUID CART SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. USING CRM TO QUERY FOR SERIAL NUMBER (B)(4), THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED BY ZIMMER BIOMET SURGICAL. ON (B)(6) 2018, IT WAS REPORTED FROM (B)(6) THAT 4 UNITS WHERE DOWN. (B)(4) MECHANICAL WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND FOUND THAT THE UNIT WAS NOT MEASURING FLUIDS CORRECTLY, AND NOTED THAT UNIT A/D VALUES WERE ABOVE 6000 ON BOTH CYLINDERS AND THE UNIT WAS NOT DRAINING COMPLETELY. HE REPLACED BOTH LEVEL SENSORS AND THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE CART TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT HAVING BEING DOWN WAS DUE TO MALFUNCTIONING LEVEL SENSORS IN BOTH CYLINDERS. THE LEVEL SENSORS ARE RESPONSIBLE FOR MEASURING THE FLUID LEVELS IN EACH CYLINDER, AND A MALFUNCTIONING LEVEL SENSOR WOULD NOT ALLOW THE UNIT TO FUNCTION AS DESIGNED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SITE INSPECTION, THE UNIT WAS FOUND TO HAVE A BAD LEVEL SENSOR. DURING INVESTIGATION, IT WAS DISCOVERED THAT BOTH LEVEL SENSORS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789598 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0019879

    Patients

    Seq Age Sex Outcome Treatment
    1