BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

    MDR report key: 23231220 · Received October 7, 2025

    Report

    Report Number
    3016746283-2025-00010
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 20, 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
    CA, 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 INVESTIGATION OF RETURNED DEVICE, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION CAN BE POSSIBLE DUE TO ACCIDENTAL DISPOSAL OF THE COMPLAINED DEVICE. CONSIDERING THIS IS THE FIRST CASE WITH THIS CLAIMED ISSUE AND THE FACT THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES FOR THE PATIENT, NO FURTHER ACTIONS HAVE DEEMED REQUIRED.

    Description of Event or Problem · 0

    (B)(6), CCP CALLED REGARDING AN ISSUE THAT THEY HAD WITH A CP22-VT, NP1001865 CENTRIFUGAL DRIVE, PH6003247. THE GOAL FLOW FOR THE PATIENT WAS 0.5 LPM, HOWEVER, THE HIGHEST FLOW THEY WERE ABLE TO ACHIEVE WAS 15 LPM NO MATTER HOW HIGH THEY TURNED UP THE RPMS. THE HIGHEST OUTLET PRESSURE THEY ACHIEVED WAS 112 MMHG, AND THE INLET PRESSURE WAS AROUND -40 MMHG. THEY THOUGHT IT COULD HAVE BEEN THE CANNULATION, BUT WHEN THEY DID A CIRCUIT CHANGE TO A BIOMEDICUS PUMP, THEY WERE ABLE TO ACHIEVE THE GOAL FLOWS. THEY DID NOT REPORT ANY ALARM OR ALERTS AT THE TIME.

    Description of Event or Problem · 0

    THE USER REPORTED AN ISSUE WITH A CP22-VT. THE GOAL FLOW FOR THE PATIENT WAS 0.5 LPM, HOWEVER, THE HIGHEST FLOW THEY WERE ABLE TO ACHIEVE WAS 15 LPM NO MATTER HOW HIGH THEY TURNED UP THE RPMS. THE HIGHEST OUTLET PRESSURE THEY ACHIEVED WAS 112 MMHG, AND THE INLET PRESSURE WAS AROUND -40 MMHG. THEY THOUGHT IT COULD HAVE BEEN THE CANNULATION, BUT WHEN THEY DID A CIRCUIT CHANGE TO A BIOMEDICUS PUMP, THEY WERE ABLE TO ACHIEVE THE GOAL FLOWS. THEY DID NOT REPORT ANY ALARM OR ALERTS AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650550 QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS CENTRIFUGAL BLOOD PUMP KFM SPECTRUM MEDICAL S.R.L. CP22V-VT G001619 08051160300624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention