BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM

    MDR report key: 7530095 · Received May 21, 2018

    Report

    Report Number
    3004582654-2018-00024
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    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) 2018 UNTIL (B)(6) 2018 (104 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. EVALUATION OF THE AFFECTED BLOOD PUMP IS ONGOING. A DETAILED ANALYSIS WILL BE PROVIDED AS SOON AS FINDINGS ARE AVAILABLE.

    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 AFFECTED PRODUCT WAS THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. AN AIR CUSHION WAS DETECTED DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AND DID NOT MEET ITS REQUIRED FUNCTIONAL PERFORMANCE. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION WHERE AN AIR CUSHION WAS DETECTED BETWEEN THE BETWEEN THE BLOOD-SIDE LAYER AND MIDDLE LAYER AND A SMALLER ONE BETWEEN THE AIR-SIDE LAYER AND MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. A MINIMAL AMOUNT OF PARTICLES WERE ALSO DETECTED IN THE MEMBRANE INTERSTICES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED .A LEAK WAS DETECTED IN THE AIR-SIDE LAYER AND ONE IN THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. BOTH LEAKS WERE LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. FURTHERMORE, GRAPHITE AGGLOMERATES WERE FOUND BETWEEN THE MEMBRANES. 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 OF THE MEMBRANE INCLUDING AT THE REGION OF THE DEFECTS. THE CAUSE OF THE FAILURE WAS MOST LIKELY THE GRAPHITE PARTICLES THAT FORMED DUE TO AN ABRASION BETWEEN THE LAYERS. THIS CAUSED INCREASED FRICTION AT POINTS,WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE AND MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2018 THAT AN INCOMPLETE EMPTYING WAS NOTED IN THE EXCOR BLOOD PUMP OF A PEDIATRIC PATIENT SUPPORTED IN THE LVAD CONFIGURATION. AN ADJUSTMENT OF THE IKUS PARAMETERS DID NOT IMPROVE THE PUMP PERFORMANCE. AFTER EVALUATING A VIDEO PROVIDED BY THE CLINIC, BERLIN HEART INC. RECOMMENDED THE REPLACEMENT OF THE AFFECTED BLOOD PUMP. THE AFFECTED EXCOR BLOOD PUMP WAS IMMEDIATELY EXCHANGED 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
    372270 EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR