BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR BLOOD PUMP PU VALVES 10 ML IN/OUT 6MM

    MDR report key: 3755455 · Received April 10, 2013

    Report

    Report Number
    3004582654-2013-00016
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BLOOD PUMP THAT IS THE SUBJECT OF THIS REPORT (S/N (B)(4)), WAS PLACED ON THE PT ON (B)(6) 2012, AND WAS REMOVED ON (B)(6) 2013 AFTER (B)(6) DAYS OF OPERATION. INITIAL VISUAL INSPECTION OF THE DEVICE SHOWS THE STABILIZING RING HAS ROTATED APPROX 180 DEGREES. PRESSURE TESTING REVEALED A MICROLEAK IN THE DRIVE MEMBRANE. PRODUCTION RECORDS REVIEW REVEALED THE EXCOR BLOOD PUMP S/N (B)(4) WAS PRODUCED ACCORDING TO SPEC AND NO ABNORMALITIES WERE FOUND IN THE RECORDS. INVESTIGATION IS ON-GOING; A DETAILED ANALYSIS OF THE PRODUCT WILL BE PROVIDED IN THE FOLLOW-UP REPORT. REF IMP NUMBER 3008454189-2013-00014.

    Description of Event or Problem · 1

    THE HOSPITAL INFORMED US THEY HAVE REPLACED A EXCOR BLOOD PUMP BECAUSE OF A REDUCED PUMP FUNCTION. THE PT WAS SUPPORTED BY A BI-VENTRICULAR SYSTEM. THEY ASSUMED A RUPTURE OF A MEMBRANE. THE LEFT HEART PUMP WAS REPLACED. PULMONARY EDEMA OCCURRED IN THE PT WHICH LEAD TO HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154207 EXCOR BLOOD PUMP PU VALVES 10 ML IN/OUT 6MM BLOOD PUMP PU VALVES DSQ BERLIN HEART GMBH P10P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Death