BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM

    MDR report key: 6258626 · Received January 17, 2017

    Report

    Report Number
    3004582654-2017-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 17, 2017
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE PUMP IN QUESTIONED S/N (B)(4) SUPPORTED THE PATIENT ADEQUATELY FOR 119 DAYS WITHOUT ANY ISSUE. THE BLOOD PUMP WAS SUBJECTED TO INTERNAL FUNCTIONAL TESTING AND THE PUMP PERFORMANCE MET ITS FUNCTIONAL SPECIFICATION, FILLING AND EMPTYING COMPLETELY. ALL THREE LAYERS OF THE TRIPLE LAYER MEMBRANE OF THE BLOOD PUMP DISPLAYED NO DEFECTS. UNDER MICROSCOPIC EXAMINATION OF THE RETURNED PUMP, A MINIMAL QUANTITY OF LOOSE GRAPHITE POWDER WAS DETECTED IN THE MEMBRANE INTERSTICES. DURING PRODUCTION OF THE EXCOR BLOOD PUMPS, GRAPHITE POWDER IS APPLIED ON BOTH SURFACES OF THE AIR-SIDE AND MIDDLE LAYER AND ONLY ON THE INNER SURFACE OF THE BLOOD-SIDE LAYER OF THE MEMBRANE, WHICH DOES NOT COME IN CONTACT WITH BLOOD. ONCE THE PUMP IS IN USE, MINIMAL GRAPHITE POWDER PARTICLES COULD COME LOOSE FROM AIR-SIDE OF THE MEMBRANE AND COLLECT ALONG THE EDGES OF THE MEMBRANE INTERSTICES. AN EVALUATION OF THE VIDEO FROM THE CLINIC COULD NOT CONFIRM ANY MOVEMENT OF THE STABILIZATION RING. ADDITIONALLY, THE STABILIZATION RING REMAINED STATIONARY IN THE APPROPRIATE POSITION, DURING TESTING OF THE RETURNED BLOOD PUMP. THE MOVEMENT OF THE MEMBRANE BETWEEN THE END POSITIONS IS VISIBLE TO OBSERVERS AND PERCEIVED AS A PULSATING MOVEMENT. THIS PULSATING MEMBRANE MOVEMENT DOES NOT REPRESENT A MOVEMENT OF THE STABILIZATION RING OR A DEFECT. DURING THE TESTING OF THE RETURNED BLOOD PUMP, SOME PUMPING SOUNDS COULD BE HEARD. THIS PUMPING SOUND CAN VARY FROM ONE PUMP TO ANOTHER. THE PUMP IN QUESTION IS NOT DEFECTIVE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE PUMP IN QUESTION S/N (B)(4) WAS IN USE FROM (B)(6) 2016. DETAILED EVALUATION OF THE RETURNED PUMP IS CURRENTLY ONGOING.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS REGARDING THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE CLINIC NOTICED GRAPHITE FORMING ON THE OUTSIDE OF THE MEMBRANE BELOW THE STABILIZATION RING. FURTHERMORE, THE CLINIC NOTED THAT THE STABILIZATION RING WAS MOVING AND MAKING A SOUND THAT APPEARED ABNORMAL. THE PUMP CONTINUED TO FILL AND EMPTY COMPLETELY, THROUGHOUT THIS EVENT. UPON REVIEWING A VIDEO FROM THE CLINIC, BERLIN HEART INC. RECOMMENDED AN EXCHANGE OF THE EXCOR BLOOD PUMP. THE BLOOD PUMP IN QUESTION WAS PROMPTLY EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE BLOOD PUMP EXCHANGE WELL WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39569 EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO