BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM

    MDR report key: 8297164 · Received February 1, 2019

    Report

    Report Number
    3004582654-2019-00010
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 1, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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). DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANE LAYERS. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT DID NOT MEET ITS REQUIRED PUMPING SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. BASED ON THE CT IMAGES, A LARGER AIR CUSHION WAS SEEN BETWEEN THE MIDDLE AND BLOOD-SIDE LAYER OF THE MEMBRANE AND SMALL AIR CUSHION WAS SEEN BETWEEN AIR AND MIDDLE LAYER OF THE MEMBRANE, AND MINIMAL SMALL PARTICLES WERE DETECTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A LEAK AS DETECTED IN THE AIR-SIDE AND MIDDLE LAYER. THE LEAK IN THE AIR-SIDE LAYER WAS LOCATED CLOSE TO THE EDGE-REGION AND THE LEAKAGE IN THE MIDDLE LAYER WAS LOCATED CLOSE TO THE CENTER . FURTHERMORE, GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES. THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS AND ALSO AT THE DEFECT LOCATIONS WERE WITHIN SPECIFICATION. THE CAUSE OF THE DEFECT 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 LAYERS OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION IN THE MEMBRANE INTERSTICES, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    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 (97 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 INSPECTION INDICATED A SUSPECTED DEFECT IN THE AIR-SIDE LAYER. A DETAILED INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING AND A REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC VIA TELEPHONE TO REPORT A REDUCED EJECTION OF THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. AN ADJUSTMENT OF THE STATIONARY DRIVING UNIT IKUS PARAMETERS DID NOT IMPROVE THE SITUATION. A MEMBRANE DEFECT WAS SUSPECTED AND THE AFFECTED PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89157 EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO