BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17265568 · Received July 6, 2023

    Report

    Report Number
    9611109-2023-00307
    Event Type
    Injury
    Date Received
    July 6, 2023
    Report Date
    August 1, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE PATIENT INJURY AND THE DEVICE CONTAMINATION FROM MYCOBACTERIUM CHIMAERA COULD BE ESTABLISHED. INDEED, A COMPLAINTS DATABASE REVIEW IDENTIFIED NO DEVICE CONTAMINATION COMPLAINTS RECEIVED FROM THIS HOSPITAL IN THE YEAR OF THE SURGERY (2011). BASED ON AVAILABLE DATA, A CAUSAL RELATIONSHIP BETWEEN LIVANOVA DEVICE AND REPORTED EVENT COULD NOT BE ESTABLISHED.

    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). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THOUGH FOLLOW UP FROM CUSTOMER LEGAL OFFICE LIVANOVA LEARNED THAT: 1) SERIAL NUMBERS OF THE 3T HEATER COOLER IN USE DURING THE PROCEDURE OR IF NOT THE SERIAL NUMBERS OF THE LIVANOVA FLEET SUPPLIED IN 2011 WERE: ¿SN (B)(6); MFG 28/11/2002; UDI N.A. ¿SN (B)(6); MFG 28/04/2006; UDI N.A. ¿SN (B)(6); MFG 15/09/2003; UDI N.A. ¿SN (B)(6); MFG 14/04/2008; UDI N.A. 2) IN 2011, THE DISINFECTION PROCEDURES WERE CARRIED OUT AS REPORTED IN THE INSTRUCTION INTERNAL OPERATIONAL DRAWN UP IN 2010. THIS OPERATING INSTRUCTION WAS DRAWN UP TO STANDARDIZE THE DISINFECTION PROCEDURES SINCE THE SUPPLIED APPLIANCES WERE PRODUCED AND SUPPLIED IN DIFFERENT PERIODS BUT, WHILE BEING THE SAME, THEY HAD DIFFERENT INSTRUCTIONS, WHICH HOWEVER WERE FULLY RESPECTED. THEY RECALL THAT, ONLY STARTING FROM 2014, THE SCIENTIFIC LITERATURE BEGINS TO WARN WITH SUFFICIENT CERTAINTY OF THE DANGER OF CONTAMINATION OF CARDIAC DEVICES BY OF THE PATHOGEN CHIMAERA. THE PADUA UNIVERSITY HOSPITAL HAS ALWAYS BEEN DILIGENTLY ADAPTED TO POST-2011 SAFETY ADVISORIES ISSUED BY LIVANOVA OR THOSE OF 06/03/2015, 06/21/2016 AND 11/11/2016. AND IN FACT, ALSO REQUESTED AND OBTAINED FROM LIVANOVA AND SORIN AN EXTRAORDINARY INTERVENTION BY DISINFECTION OF ALL HEATER COOLER DEVICES IN SERVICE AT THE INSTITUTION WHICH WAS PERFORMED ON DATE 16 AND 17 MAY 2017. IN AUGUST 2017, AT THE CARE AND EXPENSE OF LIVANOVA, A ADJUSTMENT AIMED AT EXCLUDING THE POSSIBILITY OF AEROSOL LEAKAGE THROUGH SEALING OF THE INTERNAL TANKS AND POSITIONING OF THE SUCTION SYSTEM CONNECTED WITH BLANK ON THE WALL. 3) IN 2011, NO TESTS FOR NTM DETECTION WERE PERFORMED: THIS POSSIBILITY HAS ARISEN AVAILABLE AT THE MICROBIOLOGY LABORATORY AT THE END OF 2016, WHEN IT WAS TAKEN FULL AWARENESS OF THE RISK OF CONTAMINATION, UNKNOWN AT THE TIME OF THE SPECIFIC FACTS TO WHICH IT OCCURRED REFERS TO THE PRESENT. 4) IN DECEMBER 2018, THIS COMPANY ISSUED TO SUBJECTS WHO HAD UNDERGONE A SURGERY WITH USE OF BLOOD COOLING DEVICE A CARD INFORMATION DRAWN UP BY THE VENETO REGION REGARDING THE RISK OF A POSSIBLE MYCOBACTERIUM CHIMAERA CONTAMINATION. THE PATIENT RIVIELLO JOINED THE CAMPAIGN INFORMATION AND WAS TAKEN OVER BY THE INFECTIOUS DISEASES CLINIC WITH A RESPONSE OF BACTERAEMIA FROM M. CHIMAERA AT THE SAMPLING OF 05.03.2019. LOCALIZATION FEEDBACK FOLLOWED AT THE OCULAR AND SPINAL LEVEL. 5) AMONG THE MODES OF TRANSMISSION OF THE MYCOBACTERIUM CHIMAERA IS THE TRANSMISSION BY CONTAMINATED WATER AEROSOL PRESENT IN HEATING-COOLING DEVICES (HCU HEATER-COOLER UNITS) OF THE MACHINES FOR THE EXTRACORPOREAL CIRCULATION, USED IN THE CARDIAC SURGERY AND PRODUCTS FROM LIVANOVA-SORIN. IT HAS BEEN SEEN IN LITERATURE THAT THE CONTAMINATION OF HCU DEVICES CAN OCCUR AT THE MANUFACTURING SITE LEVEL; INVESTIGATIONS CONDUCTED AT PRODUCTION SITES HAVE IN FACT CONFIRMED THE PRESENCE OF MYCOBACTERIUM CHIMAERA AT THE LEVEL OF THE ASSEMBLY AREA OF HEATER-COOLER DEVICES AND DEVICES JUST PRODUCED. 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 MALE PATIENT UNDERGONE SURGERY IN 2011, DURING WHICH A HEATER-COOLER SYSTEM 3T WAS IN USE. THE PATIENT BECAME AWARE OF HAVE CONTRACTED A MYCOBACTERIUM CHIMAERA INFECTION IN 2019. NO ADDITIONAL INFORMATION ON THE PATIENT WERE PROVIDED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991008 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other