BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 8157342 · Received December 12, 2018

    Report

    Report Number
    3004582654-2018-00064
    Event Type
    Death
    Date Received
    December 12, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 12, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). G8: ADVERSE EVENT TERM: ISCHEMIC CVA, SEPSIS.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART (B)(4) ON (B)(6) 2018 TO REPORT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION OF THE EXCOR BLOOD PUMP HAD A MAJOR INFECTION AND ISCHEMIC CVA. THE DEATH WAS THE RESULT OF SEPTIC SHOCK FROM THE INFECTION. ON (B)(6) 2018, THE PATIENT WAS FOUND VOMITING IN THE MORNING AND AN INFECTION WAS DETECTED. THE RESPONSIBLE MICROORGANISM WAS IDENTIFIED AS A FUNGUS (CANDIDA PARAPSILOSIS). ON (B)(6) 2018, THE PATIENT WAS PRESENTED WITH LOW SATURATION AND HAD TO BE INTUBATED. THE PATIENT COMPLAINED ABOUT A HEADACHE, BUT WAS AWAKE AND ABLE TO COMMUNICATE. DURING THE WEEKEND, THE PATIENT CONDITION DETERIORATED AND ON (B)(6) 2018, THE CT-SCAN SHOWED A BIG ISCHEMIC AREA AND THE PATIENTS PUPILS WERE "MYDRATIC". ON (B)(6) 2018, BRAIN DEATH WAS CONFIRMED THROUGH A METHOD (Nº2.173) PUBLISHED IN (B)(6) (NOVEMBER 23RD, 2017) BY (B)(6) THAT DETERMINES A SPECIFIC PROTOCOL USED TO CONFIRM BRAIN DEATH. THIS PROTOCOL WAS FOLLOWED STRICTLY AND TESTS WERE INITIATED ON TUESDAY (B)(6) 2018 BY A GROUP OF PHYSICIANS. THE CLINIC INFORMED US THAT THE DEATH WAS DUE TO SEPTIC SHOCK FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996425 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death| L