BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8800520 · Received July 17, 2019

    Report

    Report Number
    3004582654-2019-00065
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT COULD BE CONFIRMED. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION COULD BE DETECTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A LEAKAGE WAS NOTED IN THE AIR-SIDE LAYER LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. FURTHERMORE, A FEW GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES. THE MIDDLE AND BLOOD-SIDE LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. THE THICKNESS OF THE DEFECTIVE LAYER, AND THE ONE ADJACENT, WAS RE-MEASURED. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE TESTED LAYERS AT ALL THE FIXED LOCATIONS AND ALSO AT THE REGION OF THE LEAKAGE WAS FOUND TO BE 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 LAYER 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 · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2019 (49 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 OF THE RETURNED BLOOD PUMP IS INDICATIVE OF A MEMBRANE DEFECT. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 1

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ABOUT AN EXCHANGE OF THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC SUSPECTED REDUCED EJECTION IN THE AFFECTED BLOOD PUMP. AN ADJUSTMENT OF THE IKUS STATIONARY DRIVING UNIT PARAMETERS HAD NOT IMPROVED THE SITUATION AND THE CLINIC DECIDED TO EXCHANGE THE AFFECTED BLOOD PUMP. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS BY TRAINED PERSONNEL AT THE CLINIC. THE PATIENT WAS NOT AFFECTED BY THE INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590810 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 4 YR