BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10132946 · Received June 9, 2020

    Report

    Report Number
    9611109-2020-00339
    Event Type
    Death
    Date Received
    June 9, 2020
    Report Date
    May 13, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. 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). LIVANOVA WILL ATTEMPT TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. 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

    LIVANOVA (B)(4) BECAME AWARE THROUGH LITERATURE REVIEW OF M. CHIMAERA ISOLATE OBTAINED FROM A BONE MARROW SPECIMEN TAKEN FROM A (B)(6)-YEAR-OLD MAN HOSPITALIZED IN (B)(6) 2013 WITH A TWO-MONTH HISTORY OF PROGRESSIVE KIDNEY FAILURE, INCREASED LIVER ENZYME LEVELS, PANCYTOPENIA AND SPLENOMEGALY. FEVER WAS RECORDED AT ADMISSION AND MICROBIOLOGICAL SAMPLES AND TRANSTHORACIC ECHOCARDIOGRAPHY FINDINGS WERE INITIALLY NEGATIVE. A BONE MARROW ASPIRATE PERFORMED DUE TO PROGRESSIVE DETERIORATION AND PANCYTOPENIA DID NOT REVEAL GRANULOMAS, AND HAEMOPHAGOCYTIC SYNDROME WAS RULED OUT. FOUR WEEKS AFTER THE PATIENT WAS ADMITTED, A MAC ISOLATE WAS OBTAINED FROM THE BONE MARROW SAMPLES. BLOOD AND URINE CULTURES WERE NEGATIVE FOR MYCOBACTERIA. TRANSOESOPHAGEAL ECHOCARDIOGRAPHY PERFORMED AT THE TIME OF MAC ISOLATION SHOWED MITRAL VALVE VEGETATION, AND THE PATIENT STARTED TREATMENT WITH ETHAMBUTOL, CLARITHROMYCIN AND RIFAMPICIN, WITH RAPID RESOLUTION OF FEVER. SURGICAL TREATMENT WAS CONSIDERED BUT REJECTED DUE TO THE PATIENT¿S TERMINAL CONDITION. THE PATIENT DIED A FEW DAYS LATER. WITHIN THE ARTICLE IT IS STATED THAT A SUBSEQUENT SEARCH OF HIS CLINICAL HISTORY REVEALED AORTIC VALVE REPLACEMENT AND MITRAL REPAIR IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597757 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1