BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 19496405 · Received June 10, 2024

    Report

    Report Number
    3001587388-2022-22020
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    December 10, 2021
    Report Date
    June 10, 2024
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRESENCE OF DRY BLOOD IN THE PA TUBE CHANNEL. ERROR E001 CONFIRMED ON CONNECTION TO PRESSIO MONITOR. THE PA CATHETER TUBE IS COMPLETELY ELONGATED BETWEEN THE DONGLE SHELL AND THE Y SEPARATOR, THE MEASUREMENT SHOWS AN ELONGATION OF + 140 MM (THE THEORETICAL DISTANCE BETWEEN THESE TWO ELEMENTS IS 450 MM, IT IS MEASURED AT 590 MM). IT IS POSSIBLE TO EXTRACT THE BROKEN MICRO-CABLE FROM THE PA TUBE, BROKEN AT AROUND 130 MM FROM THE DONGLE SHELL. THIS EXPLAINS FAULT E001 (ELECTRICAL DISCONTINUITY) DUE TO THE BROKEN MICRO-CABLE IN THE PA TUBE. THE FAULT IS THEREFORE DUE TO INCORRECT USE.

    Description of Event or Problem · 0

    BEFORE THE CATHETER WAS IMPLANTED, THE SURGEON ZEROED THE CATHETER NORMALLY. FOUR HOURS AFTER CATHETER IMPLANTATION, E001 WAS DISPLAYED ON THE MONITOR. THE SURGEON AND NURSE CONFIRMED THAT THE CATHETER WAS NOT PULLED OR BROKEN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665114 SOPHYSA KIT PRESSIO® POUR MONITORING DE PIC, PARENCHYMATEUX TUNNELLISABLE, PRODUCT CODE: GWM SOPHYSA PSO-PT 01-JANV.-2026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other