BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM

    MDR report key: 7293083 · Received February 23, 2018

    Report

    Report Number
    3004582654-2018-00008
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 23, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 EXCOR BLOOD PUMP, S/N (B)(4) WAS IN USE BY THE PATIENT FROM (B)(6) 2017 UNTIL (B)(6) 2018(112 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE BLOOD PUMP IS DESIGNED WITH A TRIPLE LAYER MEMBRANE SEPARATING THE AIR CHAMBER FROM BLOOD CHAMBER FOR SAFETY REASONS. THE ENTIRE MEMBRANE CONSISTS OF AN AIR-SIDE LAYER, A MIDDLE LAYER AND A BLOOD-SIDE LAYER. IN CASE OF DISRUPTION IN ONE OF THE TRIPLE LAYERS, THERE ARE TWO MORE LAYERS THAT WILL MAINTAIN THE INTEGRITY OF THE AIR AND BLOOD CHAMBERS. INITIAL VISUAL INVESTIGATION OF THE RETURNED PUMP INDICATES A DEFECTIVE AIR-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. A DETAILED INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING.

    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 CLINIC EXCHANGED AN EXCOR BLOOD PUMP DUE TO INCOMPLETE EMPTYING. THE CLINIC PROVIDED BERLIN HEART WITH A VIDEO OF THE BLOOD PUMP AT THE TIME OF THE EVENT BASED ON WHICH IT CAN BE CONFIRMED THAT THE PUMP WAS INCOMPLETELY EMPTYING. THE AFFECTED BLOOD PUMP WAS RETURNED TO THE MANUFACTURER. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANE INTERSTICES. FUNCTIONAL TESTING INDICATED THAT THE PUMP DID NOT MEET ITS PERFORMANCE SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION BASED ON THE CT IMAGES, AIR CUSHIONS WERE VISIBLE BETWEEN THE MEMBRANE INTERSTICES. FURTHER, PARTICLES WERE VISIBLE IN THE MEMBRANE INTERSTICES. THE PUMP WAS DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER(ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. LEAKS WERE ALSO DETECTED BETWEEN THE CENTER AND THE EDGE (CLOSE TO EDGE) OF THE MIDDLE-LAYER. FURTHERMORE, GRAPHITE AGGLOMERATES WERE DETECTED IN THE MEMBRANE INTERSTICES. THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. AT THE TIME OF THE INVESTIGATION, THE MEMBRANE THICKNESS OF ALL THREE LAYERS, INCLUDING AT THE DEFECT LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CAUSE OF THE FAILURE WAS MOST LIKELY PARTICLES THAT FORMED DUE TO THE ABRASION BETWEEN THE LAYERS CAUSED INCREASED FRICTION AT SOME POINTS, WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE AND MIDDLE LAYERS. AS A RESULT OF THIS DEFECT, AIR GOT IN BETWEEN THE LAYERS AND FORMED AN AIR CUSHION, WHICH REDUCED THE PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2018 AROUND 3 AM THAT THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION WAS NO LONGER COMPLETELY EMPTYING. THE CLINIC PROVIDED BERLIN HEART INC. A VIDEO OF THE EVENT. AFTER EVALUATION OF THE VIDEO, BERLIN HEART INC. RECOMMENDED AN IMMEDIATELY EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136111 EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR