BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART EXCOR DRIVING TUBE

    MDR report key: 3755439 · Received March 5, 2013

    Report

    Report Number
    3004582654-2013-00004
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    PCK
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: (B)(4). (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4) (MFR). THE EXCOR DRIVING TUBE LOT 00002867 WAS IN USE FROM (B)(6) 2012 UNTIL ITS REPLACEMENT (DATE UNK). THE DISTRIBUTOR RETURNED IT TO THE MFR WITHOUT EXPLANATION ON (B)(6) 2013. MULTIPLE PHONE CALLS FROM (B)(6) 2013 TO THE DISTRIBUTOR DETERMINED THE DRIVE LINE WAS RETURNED TO THE DISTRIBUTOR WITH A COMPLAINT OF AN AIR LEAK. IN THE INVESTIGATION A LEAK IN THE PASSAGE FROM THINNER TO THICKER DIAMETER WAS DETECTED. IT WAS REPORTED THAT THE PT WAS VERY ACTIVE. THEREFORE IT IS VERY LIKELY THAT THE LEAKAGE WAS CAUSED BY EXTERNAL FORCES DURING THE TIME OF USAGE. IN THE END IT IS NOT POSSIBLE TO FIND DEFINITELY THE ORIGIN OF THE INITIAL DAMAGE. (B)(4).

    Description of Event or Problem · 1

    WE WERE INFORMED THAT THE HOSPITAL REPLACED A RED EXCOR DRIVING TUBE BECAUSE OF A LEAKAGE OF THE TUBE. WHEN THE INCIDENT OCCURRED THE PT WAS SUPPORTED WITH THE EXCOR STATIONARY DRIVING UNIT IKUS. WE WERE INFORMED THAT THERE WERE NO COMPLICATIONS REGARDING THE LEAKAGE OF THE EXCOR DRIVING TUBE OR AFTER THE REPLACEMENT. THE PT IS STILL SUPPORTED WITH THE EXCOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95113 BERLIN HEART EXCOR DRIVING TUBE DRIVING TUBE RED 6/8 MM PCK BERLIN HEART GMBH L20H-002X01 00002867

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR