BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR 6MM ARTERIAL CANNULA

    MDR report key: 4023190 · Received August 14, 2014

    Report

    Report Number
    3004582654-2014-00034
    Event Type
    Death
    Date Received
    August 14, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: (B)(4). THE PATIENT WAS IMPLANTED ON (B)(6) 2014 WITH A 15ML LVAD. THE PATIENT WAS CANNULATED IN THE LV APEX WITH A 9MM APICAL CANNULA AND THE AORTA WITH 6MM ARTERIAL CANNULA. THE 6MM ARTERIAL CANNULA WAS CONNECTED TO OUTFLOW CONNECTOR OF THE 15 ML BLOOD PUMP WITH A 6MM/9MM CONNECTOR SET. THE EXCOR 6MM ARTERIAL CANNULA WHICH IS THE SUBJECT OF THIS REPORT, LOT #00023009, WAS USED FROM (B)(6), 2014 TO (B)(6), 2014 (85 DAYS). THE MANUFACTURER REVIEWED THE PRODUCTION RECORDS OF THE 6MM ARTERIAL CANNULA, LOT# 00023009 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 15 ML BLOOD PUMP (1320140), 6MM/9MM CONNECTOR SET (00026212) AND 6 MM ARTERIAL CANNULA (00023009) WERE SENT FROM THE CLINICAL SITE TO DR (B)(6) FOR AN INDEPENDENT ACCORDING TO DR (B)(6), THE EVALUATION IS 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. (B)(4).

    Description of Event or Problem · 1

    BERLIN HEART INC WAS CONTACTED BY THE (B)(6) AT 7:48 AM ON (B)(6), 2014 TO INFORM CLINICAL AFFAIRS OF THE DEATH OF A BERLIN HEART PATIENT WHO HAD BEEN IMPLANTED WITH AN EXCOR PEDIATRIC 15 ML LVAD ON (B)(6), 2014. THE CHIEF OF PERFUSION STATED THAT AT APPROXIMATELY 5:00 AM THE NURSE WAS WITH THE PATIENT AND HAD JUST RETURNED TO THE NURSES STATION AND HEARD A LOUD NOISE AND RETURNED TO THE PATIENT'S ROOM TO FIND THE IKUS ALARMING AND THE PATIENT IN THE CRIB WHERE SHE HAD LEFT HIM, UNRESPONSIVE WITH A LARGE AMOUNT OF BLOOD NEAR THE PATIENT, COVERING THE MATTRESS. A CODE (EMERGENCY SITUATION) WAS CALLED AND ATTEMPTS WERE MADE TO RESUSCITATE THE PATIENT. THE VAD CANNULA DRESSING WAS REMOVED IN AN EFFORT TO IDENTIFY THE SOURCE OF THE BLEEDING WHEN THE SITE FOUND A HOLE IN THE ARTERIAL CANNULA THAT WAS LEAKING BLOOD. ATTEMPTS WERE MADE TO FIX THE CANNULA BUT WERE NOT SUCCESSFUL. THE PATIENT WAS PRONOUNCED DEAD AT APPROXIMATELY 5:44 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486151 EXCOR 6MM ARTERIAL CANNULA VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH C80G-021 00023009

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Death