BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17257780 · Received July 5, 2023

    Report

    Report Number
    9611109-2023-00299
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    February 5, 2014
    Report Date
    February 28, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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 DUBLIN, IRELAND. THIS EVENT WAS BROUGHT TO LIVANOVA¿S NOTICE BY A LAWSUIT BEING FILED, AND THE POSSIBILITY TO SPEAK WITH THE PERSON SUING US IS LIMITED BY THE RULES OF LITIGATION. HOWEVER, LIVANOVA IS WORKING IN COLLABORATION WITH ITS LEGAL DEPARTMENT TO OBTAIN ANY RELEVANT INFORMATION FROM THE COMPLAINANT. LIVANOVA WILL TIMELY SHARE WITH THE COMPETENT AUTHORITY IN A FOLLOW-UP REPORT ANY RELEVANT ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW UP COMMUNICATION, LIVANOVA LEARNED THAT POSSIBLE INVOLVED DEVICE SERIAL NUMBERS COULD BE THE FOLLOWING: (B)(6) (MANUFACTURED ON 14 MARCH 2007) OR (B)(6) (MANUFACTURED ON 16 MARCH 2007) OR 16S10220 (MANUFACTURED ON 20 SEPTEMBER 2012) (MODEL: 16-02-80). NO OTHER INFORMATION HAS BEEN MADE AVAILABLE FROM THE CUSTOMER. DHR REVIEW OF POSSIBLE INVOLVED DEVICE SERIAL NUMBERS HAS BEEN COMPLETED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO DEVICE, BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERIES (B)(6) 2014), WAS UPGRADED WITH VACUUM AND SEALING KIT. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL. ANYWAY, LIVANOVA ALREADY IMPLEMENTED A STRATEGY TO DECREASE THE PROBABILITY OF BACTERIA GROW 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.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A MALE PATIENT UNDERGOING A CARDIAC SURGERY ON (B)(6) 2014 WAS FOUND TO BE INFECTED BY MYCOBACTERIUM CHIMAERA ON (B)(6) 2016. HEATER-COOLER 3T WAS USED IN THIS SURGERY. MEDICAL PATIENT HISTORY: AORTIC STENOSIS, AORTIC INCOMPETENCE AORTIC SUB MEMBRANE, INSERTION OF CARDIAC DEFIBRILLATOR. ON (B)(6) 2016 THE PATIENT DEVELOPED A PAIN IN HIS CHEST AND HIS WOUND WAS BLEEDING. ON (B)(6) 2016 HE UNDERWENT EMERGENCY SURGERY AND REQUIRED FURTHER OPEN HEART SURGERY ON (B)(6) 2016. FOLLOWING THIS LAST SURGERY, HE WAS INFORMED THAT IT WAS FOUND EXTENSIVE BACTERIAL INFECTION ON THE GRAFT AND SURROUNDING TISSUE. AS A CONSEQUENCE, HE SUFFERED FROM DEPRESSION AND USED LONG-TERM ANTIBIOTICS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989551 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other