BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC STATION

    MDR report key: 9636098 · Received January 28, 2020

    Report

    Report Number
    0001954182-2020-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    November 19, 2019
    Report Date
    January 27, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    UDI-DI
    00889024466012
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PREVIOUS REPAIR RECORD FOR INTELLICART EVACUATION UNIT 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. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2019, A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN WAS CONTACTED ABOUT THE CART AND DISPATCHED TO BE AT THE SITE. ON (B)(6) 2019, THE TECHNICIAN ARRIVED AT THE SITE AND CONFIRMED THAT THE UNIT HAD A FLUID LEAK; THERE WAS A SPLIT IN THE PERISTALTIC TUBING. THE TECHNICIAN REPLACED THE PERISTALTIC PUMP HOSE (PART #90058) AND LEAK DETECTOR (PN 70088, LOT 0041658) THEN NOTED THE BOOTSTRAP ON THE COUPLER WAS TORN. HE REPLACED THE COUPLER (PN 70029, LOT 0041784) THEN FOUND CARTS WERE NOT COMMUNICATING. HE THEN REPLACED THE CONTROL BOARD (PN 70065, LOT 0040666) THEN VERIFIED THAT THE EVAC WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE EVAC TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT LEAKING WAS DUE TO A TORN PERISTALTIC PUMP HOSE. THE PERISTALTIC PUMP HOSE TRANSPORTS FLUID THROUGH THE UNIT TO THE DRAIN PUMP. A SPLIT IN THE TUBING CAN ALLOW FLUID TO LEAK, AS SEEN 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 PERISTALTIC PUMP HOSE AND ADDITIONAL COMPONENTS WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED PER TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING THE EVAC WAS LEAKING AND DID NOT RESULT IN HARM OR DELAY. THERE WERE EXPOSED WIRES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102776 EVAC STATION POWERED SUCTION PUMP JCX DORNOCH 00-5140-109-00 0026679 00889024466012

    Patients

    Seq Age Sex Outcome Treatment
    1