BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSOR

    MDR report key: 16521305 · Received March 10, 2023

    Report

    Report Number
    3016746283-2023-00003
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 4, 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

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER THE INVESTIGATION OF THE RETURNED DEVICE, WHICH COULD BE ADDRESSED IN A FOLLOW-UP REPORT. NO PATIENT INFORMATION WAS PROVIDED. (B)(6) 2023: INVESTIGATION REPORT ATTACHED - FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER THE INVESTIGATION OF THE RETURNED DEVICE, WHICH COULD BE ADDRESSED IN A FOLLOW-UP REPORT. NO PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    CLINICIAN CALLED TO REPORT THAT CP22 DISPOSABLE WAS CHANGED OUT DUE TO SIGNS OF HIGH HEMOLYSIS (HIGH PLASMA FREE HEMOGLOBIN AND RISING DELTA P) AFTER BEING ON ECMO FOR ~ 4 DAYS. AFTER FLUSHING THE OLD CIRCUIT, THE PRE-SIDE OF THE OXYGENATOR WAS COVERED IN HEMOLYTIC FIBERS, WHICH THEY ASSUMED HAD COME FROM THE PUMP HEAD. QWS BEING USED AT THIS TIME WAS SN(B)(6). CLINICAN IS ASKING US TO INVESTIGATE THIS DISPOSABLE FOR ANY POSSIBLE DEFECTS TO DETERMINE WHETHER THIS DEVELOPED IN THE PUMP HEAD OR WAS DRAWN IN FROM THE PATIENT. A VERY SIMILAR OCCURENCE WAS REPORTED ON (B)(6) 2022.

    Description of Event or Problem · 0

    CLINICIAN CALLED TO REPORT THAT CP22 DISPOSABLE WAS CHANGED OUT DUE TO SIGNS OF HIGH HEMOLYSIS (HIGH PLASMA FREE HEMOGLOBIN AND RISING DELTA P) AFTER BEING ON ECMO FOR 4 DAYS. AFTER FLUSHING THE OLD CIRCUIT, THE PRE-SIDE OF THE OXYGENATOR WAS COVERED IN HEMOLYTIC FIBERS, WHICH THEY ASSUMED HAD COME FROM THE PUMP HEAD. QWS BEING USED AT THIS TIME WAS SN#: (B)(4). CLINICIAN IS ASKING US TO INVESTIGATE THIS DISPOSABLE FOR ANY POSSIBLE DEFECTS TO DETERMINE WHETHER THIS DEVELOPED IN THE PUMP HEAD OR WAS DRAWN IN FROM THE PATIENT. A VERY SIMILAR OCCURENCE WAS REPORTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182042 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