BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 24511144 · Received March 4, 2026

    Report

    Report Number
    3003263092-2026-000000
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 4, 2026
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PERSONNEL MENTIONED THAT IT WAS DISCOVERED, THAT THERE WAS A LEAKAGE IN THE MURPHY CONNECTING TO THE INFUSION BAG. THE PRESSURE COULD NOT BE MAINTAINED, AND WATER WAS DRIPPING INTERMITTENTLY. 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. PICCO MONITORING KIT WAS REPLACED IMMEDIATELY WITH NEW ONE. THE VIDEO OF THE LEAKING MONITORING KIT WAS PROVIDED, WHICH CONFIRMED THE ISSUE. 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
    90976 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8215 23IC11 24250094500751

    Patients

    Seq Age Sex Outcome Treatment
    1