BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM

    MDR report key: 11423489 · Received March 5, 2021

    Report

    Report Number
    3004582654-2021-00013
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 21, 2021
    Report Date
    March 5, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION IS BEING MADE TO H10 OF THE INITIAL MDR. THE EXCOR BLOOD PUMP, S/N, (B)(4) WAS IN USE BY THE PATIENT FROM 2021-02-16 UNTIL 2021-02-21 (5 DAYS).

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N, (B)(4) WAS IN USE BY THE PATIENT FROM (B)(6) 2020 UNTIL (B)(6) 2021 (73 DAYS).

    Description of Event or Problem · 1

    BERLIN HEART WAS INFORMED BY THE SITE ON (B)(6) 2021 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM IN THE LVAD CONFIGURATION HAD DEVELOPED HEMOLYSIS FOLLOWING A PUMP CHANGE ON (B)(6) 2021. THE PUMP WAS COMPLETE FILL AND EJECTION. THE SITE REPORTED THAT THE PATIENT WAS NOT TOLERATING FEEDS AND ON (B)(6) 2021, THE PATIENT'S LDH WAS 6395 AND THE PLASMA FREE HEMOGLOBIN WAS 270. THE LDH VALUE WAS GREATER THAN 2.5 TIMES THE UPPER LIMIT OF NORMAL FOR THE SITE, THEREFORE, IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED HEMOLYSIS, RESULTING IN A REPORTABLE EVENT. THE SITE REPORTED THAT ON (B)(6) 2021, AFTER A PUMP CHANGE ON (B)(6) 2021, THE LDH WAS 3275 AND THE PLASMA FREE HEMOGLOBIN WAS 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317873 BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other