BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 22662804 · Received July 30, 2025

    Report

    Report Number
    3003263092-2025-000001
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 30, 2025
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    UDI-DI
    04250094500757
    PMA / PMN Number
    K991886
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A CRACK WAS NOTICED IN PICCO MONITORING KIT, WHAT CAUSED BLOOD BACKFLOW AND SALIN LEAKAGE. THE FAULTY PART WAS DISCARDED BY THE CUSTOMER, NO PICTURES NOR VIDEO WAS PROVIDED, SO THE ISSUE COULD NOT BE CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THERE IS NO INDICATION FOR A SYSTEMATIC ROOT CAUSE AS A DEFICIENCY OF DESIGN, PRODUCTION OR MATERIAL. OVERALL, INVESTIGATIONS DID INDICATE THAT THE DEVICE FAILED TO MEET ITS SPECIFICATION WHEN THE EVENT OCCURRED. A RELATIONSHIP BETWEEN THE DEVICE AND THE COMPLAINT IS THEREFORE CONSIDERED AS LIKELY. UPON THE COMPLAINT OCCURRENCE THE DEVICE WAS INVOLVED AND USED ON A PATIENT FOR ADVANCED HEMODYNAMIC MONITORING. IN GENERAL A MONITORING TECHNOLOGY IS CONSIDERED AS DIAGNOSTIC AID, BUT NOT DIRECTLY USED FOR DIAGNOSIS OR TREATMENT. THIS EVENT OCCURRED ON THE CHINESE MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE OUS DEVICE. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ¿PICCO MONITORING KIT¿ WHICH IS SOLD IN THE USA UNDER PRIMARY DI NUMBER (B)(4), PREMARKET SUBMISSION NUMBER K991886.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PART OF PICCO MONITORING KIT HAS DEVELOPED A CRACK, RESULTING IN BLOOD BACKFLOW IN THE LINE AND NS LEAKAGE DURING THE INJECTION OF ICE WATER. THIS EVENT DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513770 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 24AK26 04250094500757

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown