BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 10 ML IN/OUT Ø6 MM

    MDR report key: 8235538 · Received January 10, 2019

    Report

    Report Number
    3004582654-2019-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    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 CLINIC PROVIDED BERLIN HEART WITH A VIDEO OF THE BLOOD PUMP FROM THE TIME OF THE INCIDENT. BASED ON THIS, A REDUCED PUMP FUNCTION COULD NOT BE CONFIRMED, HOWEVER, A NOISE FROM THE BLOOD PUMP WAS CONFIRMED. INITIAL VISUAL INSPECTION OF THE RETURNED BLOOD PUMP DID NOT REVEAL ANY ABNORMALITIES.THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT MET ITS REQUIRED PUMPING SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. A FEW SMALL PARTICLES WERE SEEN BETWEEN THE MEMBRANES IN THE CT SCANS. NO ABNORMALITIES WERE NOTED IN ANY OF THE THREE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. ALL THREE LAYERS OF THE TRIPLE-LAYER MEMBRANE WERE FOUND TO BE INTACT. HOWEVER, THE BLOOD-SIDE LAYER OF THE MEMBRANE SHOWED A PUNCTURE-LIKE IMPRESSION, LOCATED OPPOSITE THE DE-AIRING PORT AND CORRESPONDING IN SHAPE AND SIZE OF THE DE-AIRING NEEDLE. FURTHERMORE, THE MIDDLE LAYER ALSO HAD AN IMPRESSION IN THE SAME PLACE. ADDITIONALLY, GRAPHITE AGGLOMERATES WERE SEEN BETWEEN THE MEMBRANE LAYERS. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE AIR-SIDE AND BLOOD-SIDE LAYERS AT ALL THE FIXED LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATION. AT THE TIME OF RE-MEASUREMENT, THE THICKNESS PROFILE OF THE MIDDLE LAYER WAS FOUND TO BE NOT HOMOGENOUS. A 100% PUMPING FUNCTION COULD BE CONFIRMED. PUMPING SOUNDS CAN BE HEARD WHEN THE PUMP WAS IN USE. HOWEVER, THESE ARE NOT UNUSUAL IN COMPARISON TO OTHER PUMPS. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP (AS THEY ARE MADE MANUALLY) AND THE SOUNDS HEARD WERE NOT CONSIDERED UNUSUAL OR CONSPICUOUS IN THIS CASE. THE IMPRESSIONS NOTED ON THE LAYERS ARE MOST LIKELY DUE TO THE DE-AIRING NEEDLE ACCIDENTALLY CONTACTING THE MEMBRANE LAYERS DURING PUMP PREPARATION.

    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, (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2018 UNTIL (B)(6) 2018 (41 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, (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 HAS NOT BEEN RETURNED TO THE MANUFACTURER YET. A DETAILED REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THIS PARTICULAR MODEL IS NOT AVAILABLE IN THE USA. HOWEVER, A SIMILAR DEVICE IS AVAILABLE, THEREFORE, WE ARE REPORTING UNDER THE MDR REGULATIONS.

    Description of Event or Problem · 0

    WE WERE INFORMED BY THE CLINIC THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION DISPLAYED A REDUCED EJECTION. ADDITIONALLY, THE CLINIC REPORTED AN UNUSUAL PUMPING SOUND. TRAINED PERSONNEL AT THE CLINIC EXCHANGED THE BLOOD PUMP WITHOUT INCIDENCE. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THIS INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28968 EXCOR BLOOD PUMP PU VALVES, 10 ML IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P10P-001X02

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO