BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10157645 · Received June 16, 2020

    Report

    Report Number
    9611109-2020-00350
    Event Type
    Injury
    Date Received
    June 16, 2020
    Report Date
    May 20, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. 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 (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 SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THROUGH LITERATURE REVIEW LIVANOVA LEARNED ABOUT A M. CHIMAERA INFECTION RETROSPECTIVE STUDY CONDUCTED IN (B)(6). WITHIN THE ARTICLE IS STATED THAT 9 PATIENTS RESULTED TO BE INFECTED WITH M.CHIMAERA. THIS REPORT CAPTURES 4 OVER 9 CASES SINCE FIVE (5) OF THOSE WERE ALREADY REGISTERED IN LIVANOVA DATABASE AND ALREADY REPORTED UNDER MFR REPORT NUMBERS: 9611109-2015-00525, 9611109-2015-00624, 9611109-2017-00205, 9611109-2017-00279, 9611109-2018-00165. WITHIN THE ARTICLE IT IS STATED THAT 2 PATIENT RECOVERED AND THE OTHER 7 ARE STILL UNDER TREATMENT. THESE PATIENTS HAD UNDERGONE VALVE REPLACEMENT IN SEVERAL HOSPITALS BETWEEN 2007 AND 2015 AND PRESENTED WITH ENDOCARDITIS WITH OR WITHOUT AORTIC ROOT ABSCESS OR DISSEMINATION, DEEP SURGICAL SITE INFECTION, SPINAL OSTEOMYELITIS AND DISSEMINATED DISEASE. HEATER-COOLER SYSTEMS 3T , HCU30S AND HCU40S WERE USED DURING THE MENTIONED SURGERIES (BETWEEN 2007 AND 2015). THIRTYFIVE (35) HEATER-COOLER SYSTEMS 3T , SIX (6) HCU30S AND FOUR (4) HCU40S WERE SAMPLED AT SEVERAL HOSPITAL BETWEEN FEBRUARY AND AUGUST 2015 AND TWENTYSEVEN (27) 3TS, THREE(3) HCU40S AND FOUR (4) HCU30S WERE FOUND POSITIVE TO MYCOBACTERIA. AMONG THOSE, SEVENTEEN (17) 3TS, ONE (1) HCU30 AND ONE (1) HCU40 WERE POSITIVE TO M.CHIMAERA. IT IS UNCLEAR IF THESE SAMPLED DEVICES WERE INCLUDING THE ONES ACTUALLY USED FOR THE ABOVE MENTIONED SURGERIES. THE HOSPITALS WHERE THE SURGERIES TOOK PLACE AND THE SERIAL NUMBERS OF THE DEVICES USED DURING THE PROCEDURES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620569 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Other