BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER UNIT

    MDR report key: 6553827 · Received May 6, 2017

    Report

    Report Number
    MW5069631
    Event Type
    Injury
    Date Received
    May 6, 2017
    Date of Event
    July 9, 2015
    Report Date
    May 6, 2017
    Manufacturer
    LIVANOVA PLC/ SORIN
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECENTLY RECEIVED A LETTER FROM THE REGIONAL CLAIMS DIRECTOR OF BANNER HEALTH IN (B)(6). (B)(6) ), STATING THAT I MIGHT HAVE BEEN INFECTED WITH MYCOBACTERIUM CHIMAERA DURING MY OPEN HEART SURGERY (CABBG 4X) ON (B)(6) 2015, DUE TO A DEFECT ON A HEATER-COOLER UNIT. I CONTACTED MY PCP AND SINCE I SHOW MOST OF THE SYMPTOMS FOR THIS KIND OF INFECTION, HE RECOMMENDED THAT I SHOULD BE TESTED FOR MYCOBACTERIUM CHIMAERA IMMEDIATELY. THE PROBLEM IS, THAT THIS TEST MIGHT HAVE TO BE DONE UP TO 4 TIMES AND IT IS VERY EXPENSIVE. I CANNOT AFFORD TO PAY FOR THIS TEST WITH MY DISABILITY INCOME OF (B)(6) . I CONTACTED MR. (B)(6) AND BANNER HEALTH REFUSES TO PAY FOR THIS TEST. NEEDLESS TO SAY, THAT, IF INFECTED, THIS BACTERIAL INFECTION CAN BE LIFE THREATENING. I THINK BANNER HEALTH SHOULD BE RESPONSIBLE AND PAY FOR THE NECESSARY TESTS IN FULL! COULD YOU PLEASE CONTACT THEM AND INTERVENE IN MY AND ALL OTHER PATIENT'S BEHALF. PEOPLE WILL DIE. IF BANNER HEALTH DENIES THEIR RESPONSIBILITY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332005 HEATER-COOLER UNIT HEATER-COOLER UNIT DWC LIVANOVA PLC/ SORIN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R| S BYSTOLIC| CINNAMON| COQ10| GINGER| LOSARTAN| MULTIVITAMIN| OTC MEDS: TUMERIC| PRAZOSIN| RX MEDS: DOXAZOSIN| VIIBRYD