BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 6742080 · Received July 25, 2017

    Report

    Report Number
    3004582654-2017-00018
    Event Type
    Death
    Date Received
    July 25, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 25, 2017
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). THE SITE REPORTED THAT FECAL FLUID WAS DRAINING FROM THE AORTIC CANNULA EXIT SITE. THE ORIGIN OF THE FLUID WAS THOUGHT TO BE FROM A TEAR IN THE BOWEL. THE SITE ATTRIBUTED THE DEHISCENCE OF THE CANNULA TO THE A MASSIVE INFECTION WITHIN THE CHEST CAVITY THAT WAS CAUSED BY THE LEAKING BOWEL FLUID THAT AFFECTED THE INTEGRITY OF THE AORTA. THE PATIENT WAS LOCALLY AND SYSTEMICALLY SEPTIC. NO DEVICE DEFECT WAS REPORTED, AND THE AORTIC CANNULA THAT SEPARATED FROM THE AORTA WAS REPORTED TO BE INTACT. ADVERSE EVENT TERM(S): DEATH / EXSANGUINATION.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) ON (B)(6) 2017 TO REPORT THAT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION EXPIRED DUE TO DEHISCENCE OF THE AORTIC CANNULA, THOUGHT TO BE CAUSED BY A MASSIVE INFECTION IN THE CHEST CAVITY THAT AFFECTED THE INTEGRITY OF THE AORTA, WHICH CAUSED BLEEDING AND EXSANGUINATION. ATTEMPTS WERE MADE TO RESUSCITATE THE PATIENT, BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521371 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 MO Death