BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7265185 · Received February 12, 2018

    Report

    Report Number
    0001954182-2018-00011
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 26, 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
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE (PMA/510(K) NUMBER) K081047; K123188; K133786. THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED FROM (B)(6) HEALTH CENTER THAT A UNIT WAS LEAKING FROM THE TOP OF THE CYLINDER. 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 THE UNIT WAS LEAKING FROM THE TOP. HE REPLACED THE CL500 HOUSING BUT NOTED THAT THE UNIT WAS STILL LEAKING FROM THE BOTTOM AND AN EXCHANGE WAS REQUIRED. THE LEAKING WAS NOT COVERED BY THE WARRANTY, AND THE WORK ORDER WAS CLOSED WITHOUT RESOLUTION. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. SERVICE WORK ORDER (B)(4) ON 29 JANUARY 2018. THE ROOT CAUSE FOR THE UNIT LEAKING FROM THE TOP OF THE CART WAS DUE TO STRUCTURAL DAMAGE TO THE CL500 HOUSING. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE, HOWEVER THE DEVICE WAS ALSO FOUND TO BE LEAKING FROM THE BOTTOM AS WELL. THE WORK ORDER WAS THEN CLOSED. A DAMAGED CL500 HOUSING WOULD NOT PROPERLY SEAL IN FLUIDS THAT ARE ADDED TO THE CYLINDER DURING USE AND AS SUCH WOULD ALLOW THE FLUID TO LEAK OUT ONTO THE TOP PLATE OF THE CART. 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 ULTRA DUO HIGH FLUID CART WAS LEAKING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107468 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1