BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCCO MONITORING KIT

    MDR report key: 20123882 · Received September 3, 2024

    Report

    Report Number
    3003263092-2024-00018
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Report Date
    September 3, 2024
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    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

    THE FOLLOWING SIMILAR DEVICE IS UNDER COMPLAINT: PV8215, LOT# 22JL13, CATALOGUE #6882814, MANUFACTURING DATE: 10/31/2022, EXPIRATION DATE: 09/30/2025, UDI: (B)(4). INVESTIAGATION RESULTS: IT HAS BEEN REPORTED THAT FLUID OF LESS THAN 125 ML WAS LEAKING FROM THE OUTER 3-WAY STOPCOCK (AT THE PATIENT PRESSURE LINE) DURING USE ON THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED. THE DEFECTIVE MONITORING KIT HAD BEEN REPLACED. THE DEFECTIVE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION DUE TO COUNTRY SPECIFIC RESTRICTION. UNFORTUNATELY, IT IS OUR UNDERSTANDING THAT THE PRODUCT IN QUESTION IS NOT AVAILABLE TO BE RETURNED TO US FOR ANALYSIS DUE TO COUNTRY SPECIFIC RESTRICTIONS. THERFORE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. THERE IS NO INDICATION FOR A SYSTEMATIC ROOT CAUSE AS A DEFICIENCY OF DESIGN, PRODUCTION OR MATERIAL CONSIDERING THE VERY LOW COMPLAINT RATE (< 0,01 %, CONSIDERING ROOT CAUSE). 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 IN WORST-CASE SCENARIO AS LIKELY. UPON THE COMPLAINT OCCURRENCE THE DEVICE WAS INVOLVED AND USED ON A PATIENT FOR ADVANCED HEMODYNAMIC MONITORING. THE ISSUE IS MONITORED ON A REGULARLY BASIS IN ORDER TO DETECT EARLY TRENDS. AS THERE IS NO TREND FOR THIS KIND OF ISSUE NO ADDITIONAL ACTIONS WILL BE TAKEN. WITH THE INFORMATION STATED ABOVE THE COMPLAINT WILL BE CLOSED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT FLUID OF LESS THAN 125 ML WAS LEAKING FROM THE OUTER 3-WAY STOPCOCK (AT THE PATIENT PRESSURE LINE) DURING USE ON THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED. THE DEFECTIVE MONITORING KIT HAD BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735859 PCCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV8115 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other N/A.