BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 23002992 · Received September 9, 2025

    Report

    Report Number
    3003263092-2025-000001
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 9, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN REPORTED THAT MEDICAL PERSONNEL NOTICED THAT THE ICE-WATER INJECTION POINT WAS CRACKED AND LEAKING WHILE INJECTING NS, MAKING THE PICCO MONITORING IMPOSSIBLE. NO HARM TO THE PATIENT WAS REPORTED. THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION, AS IT WAS DISCARDED BY CUSTOMER. HOWEVER, THE PICTURE OF THE LEAKING PART OF THE KIT WAS ATTACHED AND THE CRACK IS VISIBLE. 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 DURING HEMODYNAMIC MONITORING USING A PICCO MONITORING KIT THE MEDICAL PERSONEL NOTICED THAT THE ICE-WATER INJECTION POINT WAS CRACKED AND LEAKING WHILE INJECTING NS. THIS EVENT DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066108 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 24AL26 04250094500757

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male