BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 23630166 · Received November 24, 2025

    Report

    Report Number
    3003263092-2025-000002
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 26, 2025
    Report Date
    November 24, 2025
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    UDI-DI
    04250094500757
    PMA / PMN Number
    K991886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A CRACK IN STOP-COCK CONNECTOR OCCURRED, RESULTING IN BLOOD LEAKAGE FROM THE DISCONNECTED PORT. NO PATIENT HARM HAS BEEN REPORTED. THE FAULTY PART WAS DISCARDED BY THE CUSTOMER, THE PICTURE OF BROKEN PART WAS PROVIDED, SO THE ISSUE COULD 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 LEAKAGE FROM THE DISCONNECTED PORT. THIS EVENT DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749799 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 24AK26 04250094500757

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female