BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 8274108 · Received January 24, 2019

    Report

    Report Number
    0001954182-2019-00009
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 27, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
     K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPAIR RECORD FOR INTELLICART SYSTEM SERIAL NUMBER 1160337 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 1160337, THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED 4 TIMES, THE PREVIOUS REPAIR BEING FOR FLUID LEAKING FROM THE BOTTOM OF THE UNIT. THERE IS FLUID LEAKAGE ASSOCIATED WITH THE CURRENT REPAIR. THUS, THIS REPAIR WAS A RELATED ISSUE. ON 14 JANUARY 2019, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT UNIT WAS LEAKING. THE SERVICE TECHNICIAN FROM SILVER REEF BIOMEDICAL SERVICES ARRIVED AT THE SITE ON 14 JANUARY 2019 AND NOTED THAT THERE WAS FLUID IN VACUUM SYSTEM. AFTER THAT HE CREATED AND SUBMITTED THE EXCHANGE PAPERWORK FOR THE UNIT. A NEW CART WAS SHIPPED FROM RIVERSIDE TO THE HOSPITAL; THE SERVICE TECHNICIAN AGAIN ARRIVED AT THE SITE AND EXCHANGED THE UNIT ON 17 JANUARY 2019. THE DEVICE WAS TESTED AND INSTALLED WITHOUT ANY CHECKLIST. THE EXCHANGED CART WAS PICKED UP FROM THE HOSPITAL. THE EXCHANGE CART WAS CONFIRMED TO HAVE BEEN RETURNED TO RIVERSIDE ON 25 JANUARY 2019. A RETURNED EQUIPMENT LOG. UPON ARRIVAL OF THE UNIT ZIMMER BIOMET DONORCH IN HOUSE SERVICE TECHNICIAN ALSO CONFIRMED THAT UNIT HAD ARRIVED WITH FLUID IN VACUUM LINE IN CYLINDER #1 AND THE UNIT WILL BE REFURBISHED WITH NEW SERIAL NUMBER 1590010. AS PER CRM REPAIR CHECKLIST IS NOT REQUIRED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE UNIT AND THE UNIT WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER EXCHANGING THE UNIT. THE FLUID LEAK HAPPENED FROM FLUID ASPIRATED INTO VACUUM SYSTEM WHICH WAS LIKELY RAN THROUGH AND EXHAUSTED OUT OF THE CARBON FILTER. THEREFORE, THE ROOT CAUSE OF REPORTED EVENT WAS DUE TO A FLUID PRESENT IN VACUUM SYSTEM. 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 INFORMATION RECIEVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DUO FLUID CART WAS LEAKING FROM THE TOP. THE EVENT OCCURRED DURING CLEANING, AND 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
    69376 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0024180

    Patients

    Seq Age Sex Outcome Treatment
    1