BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

    MDR report key: 19890498 · Received August 2, 2024

    Report

    Report Number
    3016746283-2024-00004
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 1, 2024
    Manufacturer
    SPECTRUM MEDICAL S.R.L.
    Product Code
    KFM
    PMA / PMN Number
    K201320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    HEARD CLICKING NOISE, THOUGHT IT WAS SOMETHING TO DO WITH THE PRESSURE CABLE, PATIENT PLACED ON SUPPORT, THAT EVENING NOTICED A BLOOD STREAK FROM THE CP22 AND PUMP WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913360 CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS CENTRIFUGAL BLOOD PUMP KFM SPECTRUM MEDICAL S.R.L. CP22V-VT G001207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention