BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16342595 · Received February 9, 2023

    Report

    Report Number
    3004582654-2023-00007
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP (SN (B)(6)) WAS NOT RETURNED TO BERLIN HEART AND THEREFORE NOT AVAILABLE FOR ANALYSIS. THE PUMP RAN FOR 180 DAYS UNTIL THE TIME OF THE EVENT. ONLY ON THE BASIS OF THE PHOTOS FROM THE CLINIC THE DESCRIBED OBSERVATION REGARDING THE GRAPHITE PARTICLES COULD BE CONFIRMED. THE ABNORMALITY REPORTED IS MOST LIKELY TO BE LOOSEN GRAPHITE. DURING THE PRODUCTION OF EXCOR BLOOD PUMPS, GRAPHITE POWDER IS APPLIED TO BOTH SURFACES OF THE TM1 AND TM2, AS WELL AS TO THE INNER SURFACE OF THE BLOOD-SIDE LAYER OF THE MEMBRANE. WHILE PUMPING IN USE ON THE PATIENT, A SMALL AMOUNT OF GRAPHITE PARTICLES MAY DETACH FROM THE OUTER SURFACE OF THE TM1. IN THIS CASE, GRAPHITE PARTICLES HAVE MOST LIKELY BEEN LOOSENED BY FRICTION BETWEEN THE MEMBRANE AND THE STABILIZING RING AND HAVE VISIBLY DEPOSITED IN THE AIR CHAMBER. HOWEVER, THE PRESENCE OF GRAPHITE PARTICLES IN THE AIR CHAMBER OF THE BLOOD PUMP DOES NOT AFFECT THE FUNCTION OF THE PUMP. SINCE THE BLOOD PUMP WAS NOT RETURNED FOR EVALUATION, UNABLE TO DETERMINE THE CAUSE OF THE INCREASED LDH LEVEL OR THE REPORTED SOFT SQUEAKING NOISE. THE CLINIC HAS DECIDED TO LEAVE THE AFFECTED PUMP ON THE PATIENT. IT HAS BEEN RUNNING FOR ANOTHER 105 DAYS AND IS STILL ON THE PATIENT.

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(4), IS IN USE ON THE PATIENT SINCE (B)(6) 2022 AND AS OF (B)(6) 2023 PATIENT STILL ON THE DEVICE (186 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    THE SITE CONTACTED CLINICAL AFFAIRS ON 01.31.2023 TO DISCUSS INCREASED GRAPHITE ON THE AIR CHAMBER SIDE OF THE BLOOD PUMP. THE SITE ALSO MENTIONED THERE WERE "SOFT SQUEAKS" IN THE PUMP, BUT NOTHING OF GREAT CONCERN TO THEM. THE SITE ALSO REPORTED THAT PATIENT DOES HAVE INCREASING LDH LEVELS, 1992 AS OF (B)(6) 2023. ACCEPTABLE UPPER RANGE FOR THE SITE IS 575. CLINICAL AFFAIRS SENT A PHOTO OF THE PUMP WITH GRAPHITE SENT BY THE SITE TO BERLIN HEART GMBH FOR REVIEW. BERLIN HEART GMBH RECOMMENDED UPSIZING THE PUMP, HOWEVER, IMMEDIATE CHANGEOUT IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083204 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 2 YR Male Other