BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9634927 · Received January 27, 2020

    Report

    Report Number
    3004582654-2020-00009
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    January 4, 2020
    Report Date
    January 27, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 AND THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE LEAKAGES WERE DETECTED. THE LEAKAGE IN THE AIR-SIDE LAYER WAS LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. THE LEAKAGES IN THE MIDDLE LAYER WERE LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING AND NEAR THE CENTER. THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE LAYERS. THE THICKNESS OF ALL THREE MEMBRANE LAYERS WAS RE-MEASURED AT THE DEFINED POINTS. THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL DEFINED POINTS WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF THE RE-MEASUREMENT. IN THE AREA AROUND THE LEAKAGE, WHICH WAS NOT ONE OF THE DEFINED POINTS THAT WERE MEASURED, THE THICKNESS PROFILE OF THE AIR-SIDE LAYER AND THE MIDDLE LAYER WAS ALSO FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF THE RE-MEASUREMENT. THE CAUSE OF THE LEAKAGES IN THE AIR-SIDE LAYER AND THE MIDDLE LAYER WAS MOST LIKELY THE GRAPHITE AGGLOMERATES 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 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 EMPTYING).

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2019 UNTIL (B)(6) TIL 2020 (197 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 ON OF THE THREE 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 BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BERLIN HEART WAS CONTACTED BY THE JAPANESE DISTRIBUTOR TO REPORT A SUSPECTED MEMBRANE DEFECT OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE DISTRIBUTOR PROVIDED BERLIN HEART WITH PICTURES AND VIDEO MATERIAL OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. THE AFFECTED BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PROFESSIONALS WITHOUT COMPLICATIONS. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96061 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 2 YR