BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7165728 · Received January 4, 2018

    Report

    Report Number
    0001954182-2018-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 24, 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

    (B)(4). K081047; K123188; K133786. PRODUCT EVALUATED BY EXTERNAL CONTRACTOR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS REPAIR RECORD FOR ULTRA EVACUATION UNIT 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 DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED NINE TIMES, THE PREVIOUS REPAIR BEING FOR AN ISSUE WITH THE PICKUP STRAW ON 31 AUGUST 2017. THE PICKUP STRAW IS NOT ASSOCIATED WITH THE CURRENT REPAIR. THUS, THIS REPAIR WAS A NON-RELATED ISSUE. REPLITE WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON 08 DECEMBER 2017, THE TECHNICIAN FOUND THAT THE LEAK WAS COMING FROM THE EVAC, AND NOTED A PUNCTURED PERISTALTIC PUMP HOSE. HE REPLACED THE PERISTALTIC PUMP HOSE AND THEN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE CART WAS THEN RETURNED TO SERVICE WITHOUT INCIDENT. THE UNIT WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE OF THE REPORTED LEAKING WAS DUE TO THE PUNCTURED PERISTALTIC PUMP HOSE ON THE EVACUATION UNIT. THE SERVICE TECHNICIAN CONFIRMED THE REPORTED EVENT WHEN HE FOUND THE PUNCTURED PERISTALTIC HOSE AND NOTED THAT THE DEVICE WAS FUNCTIONING AS INTENDED AFTER REPLACING THE HOSE. 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 FLUID FROM BOTTOM OF QUAD CART. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9011 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