BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 9289543 · Received November 7, 2019

    Report

    Report Number
    9611109-2019-00874
    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 CONTAMINATION. PRE-DD LAB RESULTS SHOWN NO GROWTH OF MYCOBACTERIA AND OTHER ACID-RESISTANT BACILLI. BASED ON THE ABOVE, A CONTAMINATION OF THE SAMPLES AT THE CUSTOMER SITE CANNOT BE EXCLUDED AS POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE.

    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. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086037 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1