BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSOR

    MDR report key: 16519967 · Received March 10, 2023

    Report

    Report Number
    3016746283-2023-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    December 29, 2022
    Report Date
    March 9, 2023
    Manufacturer
    QURA S.R.L.
    Product Code
    KFM
    UDI-DI
    08051160300624
    PMA / PMN Number
    K201320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEWING DATA COLLECTED FROM THE FIELD (IMAGES AND THE CASE FILES) FROM A PRELIMINARY DOCUMENTARY ANALYSIS WE BELIEVE IT TO BE AN EMBOLISM SUCTIONED INTO THE VENOUS LINE AND DEPOSITED INTO THE CENTRIFUGAL PUMP ACUTELY. THE DATA ON THE CENTRIFUGAL PUMP MEASURING THE INLET AND OUTLET PRESSURES, AS WELL AS RPM AND FLOWS, SHOULD NOT GRADUALLY DECLINE IN PERFORMANCE. THE INLET PRESSURES SPIKED AND FLOW WAS SIGNIFICANTLY REDUCED. ACCOMPANIED BY THE PICTURES OF THE DEPOSIT IT LOOKED LIKE A THROMBUS THAT WAS STRINGY IN FORMATION AND RAVELLED AROUND THE ROTORS, LIMITING THE ABILITY FOR MECHANICAL PERFORMANCE. NO PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    CP22V-VT DISPOSABLE WAS CHANGED OUT DUE TO HIGH HEMOLYSIS (HIGH PLASMA FREE HEMOGLOBIN). AFTER CUTTING OUT THE OLD DISPOSABLE, IT WAS FOUND TO HAVE LARGE FIBRIN STRANDS WRAPPED IN THE FINS OF THE PUMP HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054869 QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSOR CENTRIFUGAL BLOOD PUMP KFM QURA S.R.L. CP22V-VT E002442 08051160300624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention