BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 9192485 · Received October 15, 2019

    Report

    Report Number
    0001954182-2019-00065
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 31, 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 · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND AS FINAL REPORT. INVESTIGATION IS COMPLETE. UDI: (B)(4). ON 03 OCTOBER 2019, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT AN INTELLICART UNIT WAS SHOWING A VACUUM SENSOR ERROR AND WAS NOT READING FLUID LEVELS CORRECTLY. ON 03 OCTOBER 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 AND CONFIRMED THE VACUUM SENSOR ERROR BUT DID NOT CONFIRM THE INCORRECT FLUID LEVEL READINGS. HE CHECKED THE VACUUM HOSES AND FOUND THEY WERE NOT AT FAULT. THE TECHNICIAN REPLACED THE CARBON FILTER (TYPE NOT NOTED) WITH A BUFFALO CARBON FILTER (PART #70208 AND LOT CODE #0040376) 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 03 OCTOBER 2019. THE ROOT CAUSE FOR THE UNIT ISSUING VACUUM SENSOR ERRORS WAS DUE TO A FAILED CARBON FILTER. THE GE CARBON FILTERS SHOW REPETITIVE ISSUES WITH RETENTION OF THE CARBON PARTICLES. THESE PARTICLES CAN CLOG THE VACUUM PUMP WHICH IN TURN DISRUPT THE AIR FLOW THROUGH THE VACUUM PUMP, PREVENTING THE COMPONENT FROM CREATING THE PRESSURE GRADIENT NEEDED TO GENERATE SUCTION. THE UNIT WILL THEN READ THAT INADEQUATE PRESSURE IS BEING GENERATED AND TRIGGER A VACUUM SENSOR ERROR. IT IS NOT NOTED WHAT TYPE OF CARBON FILTER WAS REPLACED WITH THE NEW BUFFALO FILTER. IN ADDITION, THE REPORTED EVENT OF THE UNIT NOT READING FLUID LEVELS CORRECTLY WAS NEVER CONFIRMED DURING INSPECTION OF THE DEVICE AND THERE WAS NO FAILURE FOUND THAT WOULD CAUSE THE UNIT TO READ FLUID LEVELS INCORRECTLY. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE UNIT NOT READING FLUID LEVELS CORRECTLY CANNOT BE DETERMINED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CARBON FILTER WAS REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. BASED ON THE INFORMATION PROVIDED, THIS INVESTIGATION DETERMINED THAT THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED.

    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). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS GIVING VACUUM SENSOR ERRORS AND INCORRECT FLUID READINGS IN BOTH CYLINDERS. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988572 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0024333

    Patients

    Seq Age Sex Outcome Treatment
    1