BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART EXCOR DRIVING TUBE, RED

    MDR report key: 3871203 · Received April 16, 2014

    Report

    Report Number
    3004582654-2014-00018
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)). THE EXCOR DRIVING TUBE LOT 00013616 WAS USED FROM (B)(6) 2013 TO (B)(6) 2014 FOR 7 MONTHS. THE DRIVE LINE THAT IS THE SUBJECT OF THIS REPORT WAS EVALUATED BY THE MANUFACTURE OF THE DRIVE LINE. REVIEW OF THE LOT HISTORY RECORD FOR THIS LOT AND THE MANUFACTURING PROCESS DID NOT SHOW ANY DISCREPANCY OF ANY PROBLEM RELATED TO MANUFACTURING PROCESS. THE DRIVE LINE BROKE AT THE KNOWN POSITION NEAR THE TRANSITION FROM THE THICKER TO THE THINNER SEGMENT. THIS AREA OF THE DRIVE LINE IS WHERE THE MOST STRESS IS APPLIED BY EXTERNAL FORCES DURING USAGE. EXCESSIVE EXTERNAL FORCES CAN CAUSE A LEAK OF THE DRIVE LINE. THEREFORE, EXPOSURE OF THE DRIVING TUBE TO EXCESSIVE EXTERNAL FORCES CANNOT BE EXCLUDED. IN THE END IT IS NOT POSSIBLE TO DETERMINE THE DEFINITE CAUSE OF THE INITIAL DAMAGE.

    Description of Event or Problem · 1

    SIT CALLED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT THE IKUS DRIVING UNIT WAS ALARMING WITH MESSAGE "CHECK LEFT DRIVE LINE". THE PT WAS STABLE AND THE BLOOD PUMP WAS FILLING AND EMPTYING. THE SITE EXAMINED THE DRIVE LINE AND FOUND A LEAK WITH AIR ESCAPING AT THE TRANSITION FROM THE THICKER TO THE THINNER SEGMENT JUST DISTAL TO WHERE THE DRIVE LINE CONNECTS TO THE BLOOD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233470 BERLIN HEART EXCOR DRIVING TUBE, RED VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH L20H-002X01 00013616

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR