BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8189229 · Received December 21, 2018

    Report

    Report Number
    3004582654-2018-00069
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 21, 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 2018-11-03 UNTIL 2018-12-05(32 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 REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ANALYSIS OF THE AFFECTED 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). THE CLINIC PROVIDED BERLIN HEART WITH VIDEOS OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT, BASED ON WHICH A PUMPING SOUND COULD BE CONFIRMED.THE PUMPING FUNCTION WAS NOT AFFECTED. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, A SMALL AIR CUSHION, A RED SMUDGE ON THE STABILIZATION RING AND A DEFECT IN THE AIR-SIDE MEMBRANE WERE CONFIRMED. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE LAYERS OF THE MEMBRANE LAY SLIGHTLY UNEVENLY AGAINST ONE ANOTHER. PARTICLES WERE SEEN IN THE MEMBRANE INTERSTICES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. ALL THREE MEMBRANE LAYERS DISPLAYED A PUNCTURE-LIKE LEAK AT THE SAME POSITION OPPOSITE THE DE-AIRING PORT. DRIED BLOOD RESIDUES WERE NOTED BETWEEN THE MEMBRANES, IN THE REGION OF THE LEAKAGES IN THE AIR-SIDE MEMBRANE (ON THE AIR SIDE) AND CORRESPONDINGLY ON THE STABILIZATION RING. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS AND ALSO AT THE LEAK LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATION. THE CAUSE OF THE DEFECTS IS MOST LIKELY AN ACCIDENTAL PUNCTURE OF THE MEMBRANE LAYERS WHILE DE-AIRING THE BLOOD PUMP DURING PUMP PREPARATION. THE DEFECTS ARE LOCATED FACING THE DE-AIRING PORT. BASED ON THE ENTRY AND EXIT POINTS IN THE DE-AIRING PORT, THE DIRECTION OF THE PUNCTURE COULD BE RECONSTRUCTED AND COINCIDED WITH THE DAMAGED LOCATION IN THE BLOOD-SIDE LAYER. FURTHERMORE, THE AIR-SIDE LAYER AND MIDDLE LAYER WERE PUNCTURED AT THE SAME LOCATION. A CORRELATION BETWEEN THE PUMPING SOUND AND THE DEFECTS COULD NOT BE ESTABLISHED. THE PATIENT WAS TRANSPLANTED SUCCESSFULLY ON (B)(6) 2019.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC VIA HOTLINE TO REPORT THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS FUNCTIONING CORRECTLY WITH 100% FILLING AND EMPTYING BUT THE PUMP WAS MAKING AN UNUSUAL NOISE. THE CLINIC WAS REQUESTED BY BERLIN HEART INC. CLINICAL AFFAIRS (CA) PERSONNEL TO PROVIDE A VIDEO OF THE INCIDENT. UPON EVALUATION OF VIDEO MATERIAL, CA 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
    1028633 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