BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 22964028 · Received September 4, 2025

    Report

    Report Number
    3003263092-2025-000001
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 4, 2025
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    UDI-DI
    24250094500751
    PMA / PMN Number
    K991886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING FORTH DAY OF USING PICCO MONITORING KIT ON PATIENT THE PRESSURE LINE WAS DISCOVERED BROKEN AND LEAKING. THE PICCO MONITORING KIT WAS REPLACED AND DATA WAS RESTORED. NO HARM TO THE PATIENT WAS REPORTED. THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION; THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR VIDEO. A DHR CHECK DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELATED TO THE REPORTED FAILURE. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. 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 ON THE FOURTH DAY OF USING PICCO MONITORING FOR THE PATIENT, THE NURSE DISCOVERED THAT THE PRESSURE LINE WAS BROKEN AND LEAKING. PICCO MONITORING KIT WAS REPLACED AND STABLE DATA WERE RESTORED. THIS EVENT DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018408 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 24AA03 24250094500751

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male