BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9MM

    MDR report key: 7250891 · Received February 8, 2018

    Report

    Report Number
    3004582654-2018-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 8, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 (50 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. THE 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. 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 REQUIRED SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. BASED ON THE CT IMAGES,AN AIR CUSHION BETWEEN THE BLOOD-SIDE AND MIDDLE LAYER AND A SMALLER ONE BETWEEN THE AIR-SIDE AND MIDDLE LAYER WERE VISIBLE. FOR AN AIR CUSHION TO BE ABLE TO FORM BETWEEN THE BLOOD-SIDE AND THE MIDDLE LAYER, THE AIR-SIDE AND THE MIDDLE LAYER OF THE THREE-LAYER MEMBRANE MUST HAVE A LEAK. THIS ALSO EXPLAINS WHY THE AIR-SIDE AND MIDDLE LAYER WERE NOT LYING CLOSE TO EACH OTHER. PARTICLES WERE VISIBLE IN THE MEMBRANE INTERSTICES AND ALSO BETWEEN THE STABILIZATION RING AND THE AIR- SIDE LAYER IN THE CT SCANS. THE PUMP WAS DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER(ALONG THE ROLLING RADIUS OF THE STABILIZATION RING). LEAKS WERE ALSO DETECTED CLOSE TO THE CENTER OF THE MIDDLE LAYER. FURTHERMORE, GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES.THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE MEMBRANE THICKNESS WAS FOUND TO BE WITHIN SPECIFICATION FOR ALL THREE LAYERS. THE CAUSE OF THE FAILURE WAS MOST LIKELY THE DIMINISHED GRAPHITE COATING. 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

    ON (B)(6) 2018, BERLIN HEART INC. WAS CONTACTED BY THE CLINIC WHO REPORTED THAT THE RIGHT EXCOR BLOOD PUMP (RVAD) ON A PEDIATRIC PATIENT SUPPORTED WITH EXCOR VAD SYSTEM IN A BVAD CONFIGURATION DEVELOPED REDUCED PUMP PERFORMANCE. AN ADJUSTMENT OF THE IKUS PARAMETERS DID NOT IMPROVE THE PUMP PERFORMANCE. FURTHERMORE, THE CLINIC REPORTED THAT THE PUMPING SOUND OF THE PUMP SOUNDED UNUSUAL. AFTER EVALUATING A VIDEO PROVIDED BY THE CLINIC, BERLIN HEART INC. RECOMMENDED THE REPLACEMENT OF THE AFFECTED BLOOD PUMP. THE AFFECTED RIGHT EXCOR BLOOD PUMP WAS EXCHANGED IMMEDIATELY BY TRAINED PERSONNEL AT THE CLINIC. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100123 EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR