BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR 6MM ARTERIAL CANNULA

    MDR report key: 4132618 · Received September 29, 2014

    Report

    Report Number
    3004582654-2014-00038
    Event Type
    Death
    Date Received
    September 29, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BERLIN HEART INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4) (MANUFACTURER). THE PATIENT WAS IMPLANTED ON (B)(6) 2013 WITH A 10ML LVAD WITH 6MM INFLOW AND OUTFLOW CANNULAS. THE PATIENT HAD A PUMP CHANGE TO A 25ML LVAD DUE TO THE CHILD'S GROWTH ON (B)(6) 2014. AT THAT TIME, THE 25ML PUMP WAS PLACED ALONG WITH THE 6/9 CONNECTING SET. THE EXCOR 6MM ARTERIAL CANNULA WHICH IS THE SUBJECT OF THIS REPORT, LOT #00012718, WAS USED FROM (B)(6) 2013 TO (B)(6) 2014 (424 DAYS). THE MANUFACTURER REVIEWED THE PRODUCTION RECORDS OF THE 6MM ARTERIAL CANNULA, LOT #00012718 AND FOUND THAT IT WAS PRODUCED ACCORDING TO SPECIFICATION AND NO ABNORMALITIES WERE FOUND IN THE RECORDS. THE EXCOR PEDIATRIC PRODUCTS CONNECTED TO THE PATIENT AT THE TIME OF THE INCIDENT, THE 25 ML BLOOD PUMP (1320257), 6MM/9MM CONNECTOR SET (00014264) AND 6MM ARTERIAL CANNULA (00012718) WERE SENT FROM THE CLINICAL SITE TO DR (B)(6) AT THE CARDIOVASCULAR PATHOLOGY LAB AT (B)(6) FOR AN INDEPENDENT EVALUATION. ACCORDING TO DR (B)(6), THE EVALUATION IS ONGOING. ACCORDING TO THE SITE, AT THIS TIME, THEY DO NOT PLAN TO RETURN THE PRODUCTS TO THE MANUFACTURER FOR EVALUATION. IF BERLIN HEART IS PROVIDED WITH A COPY OF DR (B)(6)'S REPORT, WE WILL PROVIDE THE FDA WITH THE RESULTS. REF IMPORTER NUMBER 3008454189-2014-00038.

    Description of Event or Problem · 1

    BERLIN HEART INC WAS CONTACTED BY THE UNIVERSITY OF (B)(6) ON (B)(6) 2014 TO INFORM CLINICAL AFFAIRS OF THE DEATH OF A BERLIN HEART PATIENT. THE NURSE REPORTED THAT SHE LAST SAW THE PATIENT LYING IN THE CRIB. WHEN SHE HEARD THE IKUS DRIVER ALARMING, SHE WENT TO CHECK ON THE PATIENT AND FOUND THE CHILD LYING IN A POOL OF BLOOD. THEY TRIED UNSUCCESSFULLY TO RESUSCITATE THE PATIENT. DURING THE RESUSCITATION EFFORT, THEY REMOVED THE CANNULA SITE DRESSING AND FOUND BLOOD LEAKING FROM THE ARTERIAL CANNULA AT THE CONNECTION TO THE 6/9 CONNECTING SET. THE SITE CLAMPED BOTH THE INFLOW AND OUTFLOW CANNULAS, REMOVED THE BLOOD PUMP AND TRIED TO CONNECT THE PATIENT TO AN ECMO CIRCUIT VIA THE EXCOR CANNULAS BUT THE PATIENT WAS ALREADY DEAD. BERLIN HEART CLINICAL AFFAIRS RECEIVED THE INFORMATION AND A PICTURE OF THE CONNECTOR AND CANNULA CONNECTION. LOG FILES WERE DOWNLOADED AND SENT. THE SITE WAS INSTRUCTED TO RETAIN THE PUMP AND CANNULA FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604197 EXCOR 6MM ARTERIAL CANNULA VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH C80G-021 00012718

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Death