BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 8387296 · Received March 4, 2019

    Report

    Report Number
    0001954182-2019-00020
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    January 21, 2019
    Report Date
    March 4, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUS REPAIR RECORD FOR INTELLICART SYSTEM SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCE'S, 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. ON (B)(6) 2019, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT AN INTELLICART UNIT HAD A POWER IV POLE THAT WAS FULLY EXTENDED AND WOULD NOT RETRACT. ON (B)(6) 2019, MOORE'S ELECTRICAL & MECHANICAL CONSTRUCTION, INC WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE ON 24 JANUARY 2019 AND FOUND THAT THE IV POLE HAD SPUN IN PLACE, AND IN DOING SO TORE THE WIRES FROM THE PLUGS AND PULLED THE PLUGS FREE FROM THE MAIN CONTROL BOARD. THE TECHNICIAN DETERMINED THAT BOTH THE IV POLE AND THE MAIN CONTROL BOARD WOULD NEED TO BE REPLACED. ON 28 JANUARY 2019, THE TECHNICIAN RETURNED AND REPLACED THE MAIN CONTROL BOARD (PART #70064 AND LOT CODE #0028813) AND INSTALLED A NEW POWER IV POLE (PART #00-5140-102-00), 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 AS PER CL ¿ REPAIR CART AND EVAC REV. 0. SERVICE WORK ORDER (B)(4) ON 21 JANUARY 2019. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE FOR THE POWER POLE BEING UNABLE TO RETRACT WAS DUE TO THE POLE ROTATING ENOUGH TO BOTH TEAR ITS WIRES AND REMOVE ITSELF FROM POWER. IF THE IV POLE IS ABLE TO SPIN FREELY DURING USE, IT CAN DO SO ENOUGH THAT IT CAN DAMAGE ITSELF AND BE UNABLE TO BE RAISED OR LOWERED AS WELL AS CAUSE DAMAGE TO OTHER COMPONENTS LIKE THE MAIN CONTROL BOARD, SUCH AS IN THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE POWER IV POLE AND MAIN CONTROL BOARD 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 THE UNIT HAD A POWER IV POLE THAT WAS FULLY EXTENDED AND CANNOT RETRACT IT. THE EVENT TIMING WAS BEFORE SURGERY. INVESTIGATION SHOWED FRAYED WIRES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181448 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0023808

    Patients

    Seq Age Sex Outcome Treatment
    1