BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARENCHYMAL PRESSIO CATHETER

    MDR report key: 7027175 · Received November 14, 2017

    Report

    Report Number
    3001587388-2017-17502
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 11, 2017
    Report Date
    May 3, 2018
    Manufacturer
    SOPHYSA SA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WAS FINALLY THROWN BY THE HOSPITAL AND COULD NOT BE ANALYZED BY SOPHYSA QUALITY DEPARTMENT. HOWEVER, INTERNAL DOCUMENTATION WAS REVIEWED AND SHOWED THAT THE CATHETER HAS BEEN MANUFACTURED IN ACCORDANCE WITH QUALITY REQUIREMENTS. FURTHER INVESTIGATION HAS BEEN PERFORMED AND AN UPDATE OF THE MONITOR HAS BEEN PROPOSED TO THE REPORTER TO CORRECT THE BUGS.

    Additional Manufacturer Narrative · 1

    THE PROBE WILL BE RETURNED BY DISTRIBUTOR TO SOPHYSA FOR ANALYZE. INTERNAL DOCUMENTATION SHOWS THAT THE CATHETER HAS BEEN MANUFACTURED IN ACCORDANCE WITH QUALITY REQUIREMENTS AND DOES NOT SHOW ANY PERFORMANCE ABNORMALITY OR ANY CAUSALITY RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE SUSPECTED DEVICE. FURTHER INVESTIGATION WILL MAKE IT POSSIBLE TO KNOW THE CAUSES OF THE APPEARANCE OF THIS INCIDENT.

    Description of Event or Problem · 1

    WHEN THE PATIENT WAS TRANSFERRED OUT OFF THE BED THE IMPLANTED CATHETER WAS PULLED. THE PRESSIO 2 MONITOR DISPLAYED A E003 ALARM AND THE PHYSICIAN CHECKED THE CATHETER CONNECTIONS. PHYSICIAN DECIDED TO REPLACE THE CATHETER EXTENSION CABLE BUT THE MONITOR CONTINUED TO DISPLAY THE ALARM SO THE CATHETER WAS REMOVED AND REPLACED BY A NEW ONE.

    Description of Event or Problem · 1

    WHEN THE PATIENT WAS TRANSFERRED OUT OFF THE BED, IT WAS PULLED. THE PRESSIO 2 MONITOR DISPLAYED A E002 ALARM AND THE PHYSICIAN CHECKED THE CATHETER CONNECTIONS. PHYSICIAN DECIDED TO REPLACE THE CATHETER EXTENSION CABLE BUT THE MONITOR CONTINUED TO DISPLAY THE ALARM, SO THE CATHETER WAS REMOVED AND REPLACED BY A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806520 PARENCHYMAL PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA SA ICP CATHETER E0306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention