BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7579849 · Received June 7, 2018

    Report

    Report Number
    0001954182-2018-00036
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 13, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PK162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI: (B)(4). NO FUNCTIONAL DEFECT WAS FOUND WITH THE DEVICE DURING EVALUATION, THEREFORE, THE COMPLAINT WILL BE PROCESSED USING ICWR0008 REV. 1. AS SUCH, NO DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW ARE REQUIRED FOR THE COMPLAINT. USING CRM TO QUERY FOR SERIAL NUMBER (B)(4), THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED BY ZIMMER BIOMET SURGICAL. ON 04 JUNE 2018, IT WAS REPORTED FROM COMMUNITY HOSPITAL SOUTH THAT A UNIT WAS LEAKING FLUID FROM THE BOTTOM DURING. LMC SERVICE SOLUTIONS WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND WAS UNABLE TO CONFIRM THE REPORTED EVENT AND NOTED NOT ISSUE WITH THE CART. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED AS PER CL ¿ REPAIR CARTS REV. 4. SERVICE WORK ORDER (B)(4) ON 04 JUNE 2018. THE REPORTED EVENT WAS NEVER CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED. THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). K081047; K123188; K133786. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS LEAKING FLUID FROM THE BOTTOM. THE EVENT OCCURRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422781 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0027358

    Patients

    Seq Age Sex Outcome Treatment
    1