BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM

    MDR report key: 7616500 · Received June 19, 2018

    Report

    Report Number
    3004582654-2018-00029
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 19, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 (B)(6) 2018 UNTIL (B)(6) 2018 (26 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 INVESTIGATION OF THE RETURNED PUMP DID NOT INDICATE ANY DEFECTS. A DETAILED INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING.

    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). DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, NO AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANES. A THROMBUS WAS VISIBLE IN THE OUTFLOW STUB. THE BLOOD PUMP WAS CLEANED AND THE THROMBUS DISLODGED. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE AND MET ITS NORMAL FUNCTIONAL SPECIFICATION REQUIREMENTS. THE MEMBRANE FUNCTION WAS FOUND TO BE NORMAL AND NO ABNORMAL PUMPING NOISE WAS HEARD. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. A VISUAL INSPECTION OF THE CT IMAGES OF THE THREE INDIVIDUAL LAYERS OF THE MEMBRANE INDICATED NO ABNORMALITIES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. ALL THREE LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS OF THE RETURNED BLOOD PUMP WAS MEASURED AT FIXED POINTS AND WAS FOUND TO BE WITHIN SPECIFICATION AT ALL POINTS. DURING THE TESTING, PUMPING SOUND WAS HEARD, HOWEVER, IT'S APPEARS TO BE NORMAL PUMPING SOUND WHEN THE PUMP WAS IN USE. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP AS THEY ARE MADE MANUALLY. IN THE CLEANED STATE, NO REDUCED PUMP PERFORMANCE COULD BE DETECTED. THE DEPOSIT (THROMBUS) IN THE OUTFLOW STUB MOST PROBABLY CONTRIBUTED TO THE REDUCED EMPTYING AT THE TIME OF THE INCIDENT. NO DEFECTS OF THE BLOOD PUMP WERE DETECTED. THE PATIENT WAS SUFFICIENTLY SUPPORTED WITH THE AFFECTED BLOOD PUMP FOR 26 DAYS.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED ON 05/20/2018 BY THE CLINIC THAT THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION WAS MAKING AN UNUSUAL PUMPING NOISE. THE PUMP FUNCTION APPEARED NORMAL AT THIS TIME. ON 05/21/2018, BERLIN HEART CLINICAL AFFAIRS (CA) ASSESSED THE AFFECTED PUMP ONSITE AND NOTICED THAT THE PUMP WAS NO LONGER EMPTYING COMPLETELY. BERLIN HEART INC. THEREFORE RECOMMENDED AN EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP. THE AFFECTED PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL. 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
    454958 EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR