BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 8759880 · Received July 3, 2019

    Report

    Report Number
    0001954182-2019-00044
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 8, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    UDI-DI
    00889024466005
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPAIR RECORD FOR INTELLICART SYSTEM 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 RECORD 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 (B)(4), THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED 4 TIMES, THE PREVIOUS REPAIR BEING FOR VACUUM PUMP, CONTROL BOARD, AND THE INSTALLATION OF AN IV POLE CLAMP ON 04 JUNE 2019. THE CONTROL BOARD IS ASSOCIATED WITH THE CURRENT REPAIR. THUS, THIS REPAIR WAS A RELATED ISSUE. ON 18 JUNE 2019, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT AN INTELLICART UNIT WAS BROKEN AND NOT DISPLAYING LEVEL. FOLLOW UP INDICATED THAT THE INCORRECT FLUID AMOUNT WAS DISPLAYED. ON 18 JUNE 2019, A REPLITE TECHNICIAN WAS ONSITE FOR A WELLNESS VISIT WHEN HE NOTED THAT THE LEVEL SENSORS WERE NOT READING FLUID LEVELS CORRECTLY. THE TECHNICIAN REPLACED THE CONTROL BOARD (PART #70064 AND LOT CODE #0040388) 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 . SERVICE WORK ORDER (B)(4) ON 18 JUNE 2019. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE UNIT DISPLAYING INCORRECT FLUID LEVELS WAS DUE TO A MALFUNCTIONING CONTROL BOARD. THE CONTROL BOARD IS THE EFFECTIVE BRAIN OF THE CART AND OVERSEES ITS ELECTRICAL FUNCTIONS; A MALFUNCTIONING CONTROL BOARD COULD CAUSE THE LEVEL SENSORS TO READ INCORRECT 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 WAS 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 · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH WILL BE FILED. EVALUATED BY EXTERNAL CONTRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS BROKEN AND WAS DISPLAYING INCORRECT FLUID AMOUNTS ON BOTH CYLINDERS. THE EVENT TIMING WAS AFTER SURGERY CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553315 DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0026114 00889024466005

    Patients

    Seq Age Sex Outcome Treatment
    1