BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8112085 · Received November 28, 2018

    Report

    Report Number
    3004582654-2018-00061
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 3, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 (18 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 AFFECTED BLOOD PUMP HAS NOT BEEN RETURNED TO THE MANUFACTURER YET. A REPORT WILL BE SUBMITTED UPON ANALYSIS OF THE RETURNED PUMP.

    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). 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 CONFIRMED BETWEEN THE AIR-SIDE LAYER AND MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. THE PUMP WAS THEN 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. ADDITIONALLY, GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANES. THE MIDDLE AND BLOOD-SIDE LAYERS WERE 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 LOCATION WAS FOUND TO BE WITHIN SPECIFICATION. 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 LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION BETWEEN THE AIR-SIDE AND MIDDLE LAYERS, CAUSING THE REDUCED PUMP PERFORMANCE(INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS NOT EJECTING COMPLETELY. AN ADJUSTMENT OF THE IKUS STATIONARY DRIVING UNIT PARAMETERS BROUGHT NO IMPROVEMENT. UPON EVALUATION OF VIDEO SENT BY THE CLINIC, BERLIN HEART INC. CA PERSONNEL RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. TRAINED PERSONNEL AT THE CLINIC EXCHANGED THE BLOOD PUMP WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950171 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 8 MO