BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 16500936 · Received March 8, 2023

    Report

    Report Number
    9611109-2023-00098
    Event Type
    Death
    Date Received
    March 8, 2023
    Report Date
    June 25, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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. 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). LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6) ITALY. DETAILED DOCUMENTATION WAS SHARED WITH LIVANOVA AND ANALYSIS REVEALED THE FOLLOWING: ON (B)(6) 2011 THE PATIENT UNDERWENT THE FIRST CARDIAC SURGERY AT (B)(6) HOSPITAL TO REPLACE THE AORTIC VALVE AND THE ASCENDING AORTA. FOR THE PERIOD BETWEEN JUNE 2011 AND FEBRUARY 2012, THE PATIENT UNDERWENT TWO (2) HOSPITALIZATIONS AT (B)(6) HOSPITAL DUE TO ASEPSY CAUSED BY E. COLI AND ISCHEMIC INJURY. ON (B)(6) 2012 THE PATIENT UNDERWENT THE SECOND CARDIAC SURGERY AT (B)(6) HOSPITAL TO REPLACE AORTIC VALVE AND THE VASCULAR PROTHESIS. FOR THE PERIOD BETWEEN AUGUST 2012 AND MARCH 2013, THE PATIENT UNDERWENT THREE (3) HOSPITALIZATIONS AT (B)(6) HOSPITAL DUE TO STAPHYLOCOCCUS INFECTION (ASEPSY) AND LONG FEVERS, A SMALL NUMBER OF PLATELETS AND SPENOMEGALY. ON (B)(6) 2013: EMOCOLTURES RESULTED POSITIVE FOR MYCOBACTERIUM CHIMAERA AND THE PATIENT STARTED ANTIBIOTIC THERAPY. FOR THE PERIOD BETWEEN 2ND FEBRUARY 2014 AND 23RD FEBRUARY 2015, THE PATIENT UNDERWENT TWO (2) HOSPITALIZATIONS AT (B)(6) HOSPITAL DUE TO HYPERPYREXIA AND SEVERE SEPSIS WITH MULTIPLE ORGAN FAILURE IN THE NEPHROLOGY DEPT. ON (B)(6) 2015, THE PATIENT DIED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LEGAL LAWSUIT HAS BEEN ISSUED AND NO OTHER INFORMATION HAS BEEN MADE AVAILABLE. DUE TO ON-GOING LITIGATION, IT IS VERY LIKELY THAT THE CUSTOMER WILL NOT RELEASE FURTHER INFORMATION RELATED TO THE STATUS OF THE DEVICES OR PATIENTS. IT IS UNKNOWN IF THE REPORTED INFECTION IS RELATED TO THE USE OF THE HEATER-COOLER DEVICE. A DHR REVIEW COULD NOT BE PERFORMED SINCE POSSIBLE SERIAL NUMBERS INVOLVED WERE NOT PROVIDED. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL. LIVANOVA 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. INVOLVED DEVICE SERIAL NUMBER REMAINED UNKNOWN AND WAS NOT EQUIPPED WITH VACUUM AND SEALING KIT SINCE UPGRADE ACTIVITY STARTED IN 2017 (EMOCOLTURES OF PATIENT RESULTED POSITIVE FOR MYCOBACTERIUM CHIMAERA IN (MAY 2013).

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A PATIENT UNDERGONE SURGERIES BETWEEN 2011 AND 2012 WAS FOUND INFECTED BY MYCOBACTERIUM CHIMAERA AND DIED ON (B)(6) 2015. DURING BOTH SURGERIES A HEATER COOLER 3T DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790386 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death