BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 14317303 · Received May 7, 2022

    Report

    Report Number
    9611109-2022-00229
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 6, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO KNOWN PATIENT INVOLVEMENT LIVANOVA (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: ADDITIONAL DOCUMENTATION REGARDING MICROBIAL TESTS CONDUCTED ON THE MACHINE WERE SHARED WITH LIVANOVA. ANALYSIS REVEALED THAT THE FIRST POSITIVE WATER SAMPLE WAS FOUND IN SEPTEMBER 2021 AND UNTIL JUNE 2022 THE DEVICE NEVER TESTED NTM NEGATIVE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONTAMINATION CAN BE RELATED TO THE LOCATION WHERE DEVICE IS USED/STORED. HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AND THE EXACT ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT : THE DEVICE WAS CLEANED REGULARLY PER THE INSTRUCTION FOR USE THE HOSPITAL DOESN'T USE RE-USABLE BLANKETS PALL FILTER IS USED FOR TAP WATER THE DEVICE IS STORED EMPTY FOR LONG TERM STORAGE H2O2 IS ADDED WHEN THE WATER IN THE TANKS IS CHANGED (EACH 7 DAYS) HEATER-COOLER SURFACES AND WATER CIRCUITS ARE CLEANED AND DISINFECTED AS PER INSTRUCTION FOR USE IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: DOCUMENTATION OF MICROBIAL TESTS PERFORMED ON THIS SPECIFIC DEVICE WAS SHARED WITH LIVANOVA. ANALYSIS OF THE PROVIDED FILE REVEALED THAT THE UNIT TESTED POSITIVE FOR NTM SINCE JANUARY 24, 2022. IN ADDITION, IT WAS FOUND THAT THE DEVICE TESTED POSITIVE FOR NTM ALSO IN SEPTEMBER, NOVEMBER AND DECEMBER 2021. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH NTM. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079173 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown