BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

    MDR report key: 23887691 · Received December 24, 2025

    Report

    Report Number
    3016746283-2025-00026
    Event Type
    Death
    Date Received
    December 24, 2025
    Date of Event
    December 19, 2025
    Report Date
    December 24, 2025
    Manufacturer
    SPECTRUM MEDICAL 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    USER REPORTED THAT THREE CASES IN A ROW HAVE EXPERIENCED HIGH PFH (PLASMA FREE HEMOGLOBIN). IT WAS REPORTED THAT ALL THREE WERE DIFFERENT LOT NUMBERS. UNKNOWN THE PREVIOUS TWO LOT NUMBERS FOR THIS REPORT. THE HOSPITAL RECENTLY CHANGED LAB MACHINES FOR MEASURING PFH. NEW MACHINE REGISTERED MUCH HIGHER. THEY WERE NOT ABLE TO COMPARE ON PREVIOUS CASES, BUT THIS CASE THEY DID. PFH NEW MACHINE 200 AND 230 AND OLD METHOD WAS 50 AND 74 RESPECTIVELY. CASE BEFORE (TWO SAMPLES) WITH NEW MACHINE 350 AND 1040. CASE 3 BEFORE THAT TWO SAMPLE 220 AND 250. THEY USE MEDTRONIC TUBING AND EOS OXYGENATORS. RPM WAS REPORTED TO BE 3500-4000 TO MAINTAIN A FLOW OF 150 ML/KG (FLOW OF 0.55 LPM). SEEMS ELEVATED, BUT THE USER DID NOT IDENTIFY ANY REASON FOR IT. LINE PRESSURES 190-220 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057042 QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS CENTRIFUGAL BLOOD PUMP KFM SPECTRUM MEDICAL S.R.L. CP22V-VT H000460 08051160300624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death