BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART

    MDR report key: 7149155 · Received December 27, 2017

    Report

    Report Number
    0001954182-2017-00041
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 30, 2017
    Report Date
    January 17, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G5 (PMA NO): K081047; K123188; K133786. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. WILL BE EVALUATED BY EXTERNAL CONTRACTOR.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) FOR ULTRA DUO FLEX FLUID CART WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED BY ZIMMER BIOMET SURGICAL. REPLITE WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND CONFIRMED THAT BOTH CYLINDERS WERE LEAKING AIR AT THE CL-500 HOUSING. HE REPLACED THE CL-500 HOUSING AND THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE CART TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT LEAKING AROUND THE CYLINDERS BETWEEN THE TOP PLATE AND BOTTOM PLATE WAS DUE TO A DEFECTIVE CL-500 HOUSING. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CL-500 HOUSING 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 · 1

    IT WAS REPORTED THAT THE UNIT WAS LEAKING AROUND THE CYLINDER BETWEEN THE TOP PLATE AND THE BOTTOM PLATE ON THE RIGHT SIDE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927245 ULTRA DUO HIGH FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1