BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES;30 ML;IN/OUT 9 MM

    MDR report key: 5116721 · Received October 1, 2015

    Report

    Report Number
    3004582654-2015-00021
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 4, 2015
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS USED FROM (B)(6) 2015 TO (B)(6) 2015 (87 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. ANALYSIS OF THE EXCOR BLOOD PUMP IN QUESTION IS CURRENTLY ONGOING. RESULTS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). A DRIVELINE CONNECTOR (BARB CONNECTOR) CAN BE FOUND ON THE AIR CHAMBER OF THE BLOOD PUMP. THIS BARB CONNECTOR IS ASSEMBLED INTO THE PUMP THROUGH THE PU AIR CHAMBER TUBE STUB ON THE PUMP HOUSING AND SECURED USING 1-EAR CLAMP UNDER WHICH A SLIDING RING IS POSITIONED. THE BLOOD PUMP WAS RETURNED WITH CONNECTED DRIVELINE. DURING FIRST VISUAL INVESTIGATION NO ANOMALIES OF THE CONNECTOR OF THE BLOOD PUMP WERE DETECTED. IN THE NEXT STEP THE BLOOD PUMP WAS TEST VIA FUNCTIONAL TESTING AND NO FUNCTIONAL IMPAIRMENT WAS DETECTED. THE PUMP WAS FILLING AND EMPTYING AS INTENDED. FURTHER, THE BLOOD PUMP WAS TESTED IN WATER BATH SIMILAR TO THE TEST PERFORMED BY THE CLINIC. IT WAS DETECTED, THAT ONLY WHEN THE DRIVELINE KINKED SLIGHTLY, A MINIMAL AMOUNT OF DRIVING AIR IS LEAKING AT THE CONNECTOR OF THE BLOOD PUMP. THE CONNECTED DRIVELINE ITSELF SHOWS NO DEFECT. AFTER REMOVING THE CLAMP AND THE CONNECTOR, IT WAS OBSERVED THAT THE SLIDING RING OF THE 1-EAR-CLAMP, CREATED AN INDENTATION ON THE PU AIR CHAMBER STUB. DUE TO THIS INDENTATION FROM THE SLIDING RING, A SMALL AIR CHANNEL WAS CREATED INSIDE THE PU AIR CHAMBER STUB ALLOWING A MINIMAL AMOUNT OF AIR TO ESCAPE AT THE CONNECTOR. THE INDENTATION OF THE SLIDING RING WAS FORMED MOST PROBABLY WHEN ASSEMBLING THE 1-EAR-CLAMP DURING MANUFACTURING. THE PROPER CONNECTION OF THE DRIVE LINE WAS NOT AFFECTED HEREBY, THE DRIVE LINE WAS CONNECTED SAFELY. NO IMPAIRMENT OF THE BLOOD PUMP FUNCTION.

    Description of Event or Problem · 1

    MANUFACTURER WAS INFORMED BY THE HOSPITAL THAT AN INCIDENT OCCURRED WITH A PATIENT SUPPORTED IN BVAD CONFIGURATION WITH OUR EXCOR VAD SYSTEM. THE SITE HAS OBSERVED SMALL AMOUNT OF AIR LEAKAGE AT THE CONNECTOR FOR THE DRIVING TUBE OF THE LEFT EXCOR BLOOD PUMP. THEREFORE THE CLINIC EXCHANGED THE LEFT EXCOR BLOOD PUMP. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND WE WERE INFORMED THAT SHE IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651268 EXCOR BLOOD PUMP PU VALVES;30 ML;IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO