BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 24034979 · Received January 12, 2026

    Report

    Report Number
    3003263092-2026-000000
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 11, 2025
    Report Date
    January 12, 2026
    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

    MEDICAL PERSONNEL MENTIONED THAT ARTERIAL CATHETERIZATION FOR THE PATIENT WAS PERFORMED. DURING THE PROCESS OF PRIMING THE TUBING, IT WAS DISCOVERED THAT THERE WAS SEVERE LEAKAGE AT THE CONNECTION BETWEEN THE LINE AND THE MURPHY DRIP CHAMBER. A LEAKAGE IN THE ARTERIAL BLOOD PRESSURE SYSTEM COULD RESULT IN A BLOOD LOSS DEFINED AS A SERIOUS INJURY BUT IN THIS CASE NO BLOOD LEAKAGE OCCURRED. THE VIDEO OF THE LEAKING MONITORING KIT WAS PROVIDED, WHICH CONFIRMED THE ISSUE. NO PATIENT HARM HAS BEEN REPORTED. THE FAULTY PART WAS DISCARDED BY CUSTOMER. THE CAUSE OF THE ISSUE COULD BE DETERMINED AS RELATED TO CRACKED PICCO MONITORING KIT. 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 PICCO MONITORING KIT HAD A CRACK, RESULTING IN FLUID LEAKAGE. THE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99975 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE 6882817 24CA12 04250094500757

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male