BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM

    MDR report key: 7327275 · Received March 9, 2018

    Report

    Report Number
    3004582654-2018-00011
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 (B)(6) 2017 UNTIL (B)(6) 2018 (269 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. THE AFFECTED PUMP WAS RETURNED TO THE MANUFACTURER ON 2018-03-08. INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING AND A DETAILED REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    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 EXCHANGED THE EXCOR BLOOD PUMP OF A PATIENT DUE TO UNUSUAL NOISE DURING PUMP FUNCTION AND BLOOD DETECTED AROUND THE STABILIZATION RING. GRAPHITE WAS ALSO NOTED IN THE AIR CHAMBER. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, NO BLOOD WAS VISIBLE WITHIN OR OUTSIDE THE PUMP HOUSING. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AND MET ITS REQUIRED SPECIFICATION. NO UNUSUAL PUMPING SOUNDS WERE OBSERVED DURING OPERATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. BASED ON THE CT IMAGES, NO AIR CUSHIONS COULD BE DETECTED. HOWEVER,A MINIMAL AMOUNT OF PARTICLES WERE DETECTED IN THE MEMBRANE INTERSTICES. AN INSPECTION OF THE CT SCANS OF THE INDIVIDUAL LAYERS INDICATED NO DEFECTS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. TWO LEAKS WERE DETECTED IN THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE CLOSE TO THE CENTER OF THE MEMBRANE AND GRAPHITE AGGLOMERATES WERE DETECTED IN THE MEMBRANE INTERSTICES. THE OTHER TWO LAYERS OF THE MEMBRANE WERE FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF EACH OF THE THREE LAYERS AT THE FIXED LOCATIONS AND IN THE REGION OF THE DEFECT WAS FOUND TO BE WITHIN SPECIFICATION. IN THIS CASE, THE PUMPING SOUND WAS ASSESSED AS NORMAL. THE FLECKS OF BLOOD VISIBLE IN THE VIDEO FROM THE CLINIC, COULD NOT BE CONFIRMED DURING ANALYSIS OF THE RETURNED PUMP. DURING PUMPING ACTION ON THE PATIENT, A SMALL AMOUNT OF GRAPHITE PARTICLES MAY BE RELEASED FROM THE OUTER SURFACE OF THE AIR-SIDE LAYER. THE CAUSE OF THE DEFECT IN THE MIDDLE LAYER WAS MOST LIKELY DUE THE PARTICLES THAT FORMED DUE TO THE ABRASION BETWEEN THE LAYERS CAUSED INCREASED FRICTION AT SOME POINTS, WHICH FINALLY LED TO THE DEFECT IN THE MIDDLE LAYER. THE BLOOD PUMP CONTINUED TO FILL AND EMPTY FULLY AS INTENDED. THE PATIENT WAS SUFFICIENTLY SUPPORTED WITH THE AFFECTED BLOOD PUMP FOR 269 DAYS.

    Description of Event or Problem · 0

    BERLIN HEART (B)(4) WAS INFORMED BY THE CLINIC THAT BLOOD WAS VISIBLE BETWEEN THE MEMBRANE INTERSTICES, AROUND THE STABILIZATION RING, OF A PATIENT SUPPORTED WITH AN EXCOR BLOOD PUMP IN THE LVAD CONFIGURATION. THE CLINIC ALSO REPORTED THAT THE PUMP MADE AN UNUSUAL SOUND. THE CLINIC PROVIDED BERLIN HEART A VIDEO OF THE EVENT. AFTER EVALUATION OF THE VIDEO, THE MANUFACTURER RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP. THE AFFECTED EXCOR BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL IN THE CLINIC. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169478 EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR