BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 9289542 · Received November 7, 2019

    Report

    Report Number
    9611109-2019-00872
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 6, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: THE DEVICE WAS RECEIVED AT THE MANUFACTURER SITE IN ORDER TO UNDERGO DEEP DISINFECTION PROCESS. LIVANOVA PERFORMS TESTS BEFORE THE DEEP DISINFECTION IS PERFORMED (PRE-DD TESTS). RESULTS OF THE LAB TESTS DID NOT CONFIRM THE REPORTED M.CHIMAERA CONTAMINATION. PRE-DD LAB RESULTS SHOWN NO GROWTH OF MYCOBACTERIA AND OTHER ACID-RESISTANT BACILLI. HOWEVER, A BACTERIAL COUNT EXCEEDING THE PRESCRIBED LIMITS HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). 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. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA (B)(4) LEARNED THAT THE DEVICE WAS CLEANED REGULARLY PER THE INSTRUCTION FOR USE AND THAT THE DEVICE WAS PLACED OUTSIDE THE OPERATION THEATRE. THROUGH FURTHER FOLLOW-UP COMMUNICATION LIVANOVA (B)(4) LEARNED THAT THE SAMPLES ARE TESTED RANDOMLY ONCE A MONTH AND NOT AT THE DISINFECTION CYCLE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA. THE LABORATORY REPORT HAS BEEN PROVIDED. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086036 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1