BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM

    MDR report key: 11596447 · Received March 31, 2021

    Report

    Report Number
    3004582654-2021-00021
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 14, 2021
    Report Date
    March 31, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION WAS DETECTED BETWEEN MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY EXAMINED. IN THE AIR-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE A LEAKAGE WAS DETECTED, IN THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE SEVERAL LEAKAGES WERE DETECTED. THE LEAKAGES IN BOTH LAYERS WERE LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. GRAPHITE ABRASION WAS DETECTED BETWEEN THE MEMBRANE LAYERS. THE CAUSE OF THE LEAKAGES IN THE AIR-SIDE LAYER AND THE MIDDLE LAYER WAS MOST LIKELY GRAPHITE ABRASION BETWEEN THE LAYERS. THIS CAUSED INCREASED FRICTION AT POINTS, WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE LAYER AND THE MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN BETWEEN THE MEMBRANE LAYERS AND FORMED AN AIR CUSHION IN THE MEMBRANE INTERSTICES, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EJECTION).

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4) , WAS IN USE BY THE PATIENT FROM (B)(6) 2020 UNTIL (B)(6) 2021 (91 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. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 1

    BERLIN HEART WAS CONTACTED BY THE CLINIC TO REPORT A SUSPECTED MEMBRANE DEFECT DUE TO DECREASED EJECTION FROM THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC ATTEMPTED TWICE TO IMPROVE THE EJECTION OF THE PUMP BY INCREASING THE SYSTOLIC PRESSURE. THE ADJUSTMENTS MADE NO IMPROVEMENT. A MEMBRANE DEFECT WAS SUSPECTED. THE AFFECTED BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492027 BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR