BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 18417464 · Received December 29, 2023

    Report

    Report Number
    9611109-2023-00664
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 4, 2023
    Report Date
    April 10, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP, LIVANOVA WAS INFORMED THE HOSPITAL DOES NOT USE REUSABLE BLANKETS, THE WATER QUALITY MONITORING IS APPLIED AND THE H2O2 CHECKED EVERY DAY AS PRESCRIBED BY THE IFU, THE DEVICE IS USED ALMOST EVERYDAY EXCEPT THE WEEKEND, DEVICE IS STORED FULL AND THE H2O2 IS CHECKED DAILY EVEN DURING DAYS OF NON-USE (I.E. WEEK-END), H2O2 IS ADDED WHEN THE WATER IN THE TANKS IS CHANGED (EACH 7 DAYS), A DISPOSABLE PALL-AQUASAFE WATER FILTER WITH AN 0.2 M MEMBRANE IS USED FOR TAP WATER OR EQUIVALENT PERFORMANCE FILTER, PRIOR TO INITIAL OPERATION AND PRIOR TO STORING THE HEATER-COOLER, THE SURFACES AND WATER CIRCUITS ARE DISINFECTED, DEVICE SURFACES ARE NOT DISINFECTED AFTER EVERY OPERATION AND ARE DISINFECTED ONCE A WEEK (THIS IS NOT IN LINE WITH PRODUCT IFU), THE 3T AEROSOL COLLECTION SET IS REPLACED AFTER THE ALLOWED USE PERIOD, THE DEVICE IS PLACED OUTSIDE OF THE OPERATION THEATRE DURING USE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT CLEANED AFTER EVERY USE AND THIS IS NOT IN ACCORDANCE WITH IFU'S. THEREFORE, IT CANNOT BE EXCLUDED THAT HIGHLIGHTED DEVIATION FROM IFU'S MAY HAVE CONTRIBUTED TO REPORTED CONTAMINATION. LIVANOVA HAS IMPLEMENTED A STRATEGY TO PROGRESSIVELY DECREASE THE PROBABILITY OF BACTERIA GROWTH IN THE HC DEVICE BY APPLYING MULTIPLE MEASURES IMPLEMENTED OVER THE PAST FEW YEARS THROUGH DEDICATED CAPA AND FIELD ACTION. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN HASSELT, BELGIUM. LIVANOVA INITIATED AN INVESTIGATION. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE MICROBIOLOGICALLY CONTAMINATED DURING WATER SAMPLING TEST. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241333 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown