BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3957615 · Received July 14, 2014

    Report

    Report Number
    3004582654-2014-00030
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: (B)(4). BERLIN HEART INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4). THE EXCOR BLOOD PUMP, SERIAL #(B)(4), WAS USED FROM (B)(6), 2014 (72) DAYS. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP SERIAL #(B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPEC AND NO ABNORMALITIES WERE FOUND IN THE RECORDS. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. DURING INITIAL GROSS EVAL, NO DEFECT WAS REVEALED. FURTHER EVAL OF THE BLOOD PUMP SERIAL #(B)(4) IS STILL ONGOING. (B)(4).

    Description of Event or Problem · 1

    THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2014 TO INQUIRE ABOUT A SUSPECTED ABNORMAL MOVEMENT OF THE LVAD EXCOR BLOOD PUMP IN A PT SUPPORTED BY BIVAD CONFIGURATION. THE SITE DESCRIBED THAT ONE SIDE OF THE STABILIZATION RING APPEARS TO BE SLIGHTLY MOVING UPWARDS DURING THE PUMP CYCLE. THE SITE SENT A VIDEO OF THE PUMP. THE SITE REPORTED THAT PUMP IS FUNCTIONING NORMALLY DESPITE THE ABNORMAL MOVEMENT AND THE PT DID NOT EXPERIENCE ANY UNTOWARD EFFECTS FROM THE PUMP. AFTER VIEWING THE VIDEO SENT BY THE SITE, BERLIN HEART SUGGESTED THAT THE SITE CONTINUES TO MONITOR THE PUMP AND SEND A VIDEOS OF THE PUMP DAILY. ON (B)(6) 2014, THE SITE DECIDED THAT THEY WERE UNCOMFORTABLE WITH THE MOVEMENT AND CHANGED THE PUMP. THE PT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE BLOOD PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410063 EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT 6 MM VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH P10P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO