BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 19558653 · Received June 18, 2024

    Report

    Report Number
    3004582654-2024-00029
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 31, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6) WAS ON THE PATIENT SINCE (B)(6) 2024 UNTIL THE TIME OF THE EVENT ON 2024-05-31 (97 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(6) . THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    ON 2024-06-11 THE EXCOR BLOOD PUMP PU VALVES (SN (B)(6) ) , WAS RETURNED TO BERLIN HEART GMBH FOR INVESTIGATION. DURING INITIAL VISUAL INSPECTION OF THE RETURNED BLOOD PUMP, NO ABNORMALITIES WERE FOUND. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE. THE PUMP'S PERFORMANCE MET THE SPECIFICATIONS. THE PUMP WAS COMPLETELY FILLING AND EMPTYING, AND THE MEMBRANE MOVEMENT SHOWED NO ABNORMALITIES. THE "ORANGE PEEL" APPEARANCE CLAIMED WAS VISIBLE IN THE VIDEO PROVIDED BY THE SITE, HOWEVER IT WAS NOT DETECTED ON THE RETURNED BLOOD PUMP DURING TESTING IT, USING THE PARAMETERS OF THE CLINIC. OPERATING NOISES COULD BE HEARD DURING THE TEST. THE CLINIC PROVIDED BERLIN HEART WITH TWO AUDIO RECORDINGS OF THE BLOOD PUMP AT THE TIME OF THE EVENT. WHILE NOTHING COULD BE HEARD ON ONE AUDIO TRACK, CLEAR OPERATING NOISES COULD BE CONFIRMED ON THE OTHER AUDIO TRACK. THESE WERE VERY SIMILAR TO THE NOISES DETECTED DURING THE FUNCTIONAL TEST. FOR FURTHER EVALUATION, THE BLOOD PUMP WAS OPENED AND ALL PARTS THAT CONTRIBUTE TO PUMPING NOISES DURING OPERATION WERE CHECKED. ALL THREE LAYERS OF THE MEMBRANE WERE INTACT AND THE GRAPHITE DISTRIBUTION WAS UNIFORM WITHOUT ANY GAPS. THE STABILIZATION RING WAS WITHOUT ANY DEFECTS. THE SOUND IN QUESTION IS AN OPERATING SOUND WHICH HAS RECENTLY BEEN DESCRIBED AS "CRUNCHING" IN OTHER COMPLAINTS AS WELL. FUNCTIONAL TESTING OF THE BLOOD PUMPS IN THOSE CASES REVEALED THAT THIS "CRUNCHING" NOISE DOES NOT INDICATE DAMAGE OR A MALFUNCTION. ALL BLOOD PUMPS EXAMINED SO FAR, INCLUDING THE AFFECTED BLOOD PUMP FOR THIS COMPLAINT, MET THE FUNCTIONAL SPECIFICATIONS OF THE MANUFACTURER. THE PUMPING SOUNDS MAY CHANGE OVER TIME AND HAVE NO ADVERSE IMPACT ON PERFORMANCE OF THE DEVICE. FURTHER, NO VIBRATION OF THE VALVE LEAFLETS WAS DETECTED. THEREFORE, THE CORRELATION BETWEEN THE PUMP FUNCTION AND INCREASED HEMOLYSIS VALUES OF THE PATIENT COULD NOT BE DETERMINED. NO FAILURE WAS OBSERVED AND THE BLOOD PUMP FUNCTIONED AS INTENDED. THERE IS A TYPO "ASSISST" IN THE BOX D.2 OF THE INITIAL REPORT, HENCE IT HAS BEEN CORRECTED.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2024 TO REPORT THAT THE PUMP HAD A "CRUNCHING SOUND' ON A PATIENT BEING SUPPORTED WITH EXCOR BLOOD PUMP PU VALVES; 25 ML, IN/OUT Ø9MM. CA ADVISED LOWERING SYSTOLIC DRIVING PRESSURES, MONITOR HEMOLYSIS LABS, AND WATCH FOR ADDITIONAL GRAPHITE POWDER. CA EMPHASIZED THAT LOWER SYSTOLIC DRIVING PRESSURES MIGHT MITIGATE "CRUNCHING SOUND." CA ADVISED MONITORING LABS AND WATCH FOR ANY CHANGES IN PUMP FUNCTION. THE LDH VALUES WERE BASELINE HIGH 4.4K, 3.7K, 4.4K OVER THE LAST 11 DAYS. THE UPPER LIMIT OF NORMAL FOR THE LDH AT THIS HOSPITAL IS 321 U/L. THE PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. ON (B)(6) 2024, AFTER CONTACTING THE SITE, CA RECOMMENDED FOR A PUMP CHANGE AS THE SITE CONTINUED TO BE CONCERNED. PER SITE, THERE HAVE BEEN DISCUSSIONS ABOUT UP-SIZING OUTFLOW CANNULA AND CHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262697 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P25P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Male Other