BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8275511 · Received January 24, 2019

    Report

    Report Number
    3004582654-2019-00008
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 21, 2019
    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
    NURSE

    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 CLINIC PROVIDED BERLIN HEART WITH A VIDEO OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT, BASED ON WHICH THE SOUND PRODUCED BY THE PUMP CAN BE CONFIRMED. THE PUMP WAS RETURNED TO BERLIN HEART FOLLOWING THE EXCHANGE. THE INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP DID NOT REVEAL ANY ABNORMALITIES. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE AND MET ITS REQUIRED PERFORMANCE SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE LAYERS OF THE TRIPLE LAYER MEMBRANE LAY PARALLEL TO ONE ANOTHER. A FEW SMALL PARTICLES WERE DETECTED BETWEEN THE MEMBRANE LAYERS. A LEAK WAS DETECTED IN THE MIDDLE LAYER. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. A LEAK WAS DETECTED IN THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE, LOCATED BETWEEN THE CENTER AND EDGE REGION. GRAPHITE AGGLOMERATES WERE NOTED BETWEEN THE MEMBRANES. THE OTHER TWO LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS AT ALL THE FIXED MEASUREMENT POINTS INCLUDING AT THE REGION OF THE LEAKAGE WERE WITHIN SPECIFICATION. PUMPING SOUNDS CAN BE HEARD WHEN THE PUMP WAS IN USE. HOWEVER, THESE ARE NOT UNUSUAL IN COMPARISON TO OTHER PUMPS. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP AS THEY ARE MADE MANUALLY AND THE SOUNDS HEARD WERE NOT CONSIDERED UNUSUAL OR CONSPICUOUS IN THIS CASE. A CORRELATION BETWEEN THE PUMPING SOUND AND THE LEAK DETECTED IN THE MIDDLE LAYER COULD NOT BE ESTABLISHED. THE CAUSE OF THE DEFECT IN THE MIDDLE LAYER 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 MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE.

    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) 2019 (28 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. INVESTIGATION OF THE AFFECTED BLOOD PUMP IS CURRENTLY ONGOING AND A DETAILED REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS MAKING AN UNUSUAL CRINKLING NOISE. A VIDEO FROM THE CLINIC WAS REVIEWED BY BERLIN HEART INC. CLINICAL AFFAIRS AND AN EXCHANGE OF THE AFFECTED PUMP WAS RECOMMENDED. 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
    66015 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