BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM CONTROL UNIT 4.0

    MDR report key: 15921326 · Received December 5, 2022

    Report

    Report Number
    3013508628-2022-00007
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 5, 2022
    Manufacturer
    IRRAS USA INC.
    Product Code
    GWM
    PMA / PMN Number
    K200807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO PATIENTS AT (B)(6) HOSPITAL WERE UNDER TREATMENT USING THE IRRAFLOW AFES. ONE PATIENT EXPERIENCED A DELAY IN TREATMENTY SECONDARY TO AN IRRAFLOW CONTROL UNIT 4.0 BUBBLE SENSOR FAILING TO SENSE BUBBLES IN TUBE SET/ CASSETTE TUBING. ANOTHER CONTROL UNIT WAS NOT AVAILABLE. THIS CAUSED AN INTERRUPTION IN PATIENT CARE AND ABILITY FOR THE PATIENT TO RECEIVE TREATMENT AND DRAIN FOR 1+HOUR SINCE NO BACK UP CONTROL UNIT WAS AVAILABLE ON SITE, SINCE 2 IRRAFLOW PATIENTS WERE RUNNING. A PATIENT NEEDED TO BE SWITCHED TO A STANDARD EVD ACCUDRAIN AND WORKING SYSTEM EXCHANGED TO CONTINUE TREATMENT AND MONITORING OF ICP. THE SUBJECT DEVICE WAS RETURNED AND THE MALFUNCTION OF THE BUBBLE SENSOR WAS CONFIRMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958928 IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM CONTROL UNIT 4.0 INTRACRANIAL PRESSURE MONITOR GWM IRRAS USA INC. 4.0 20273000401(11)220801(21)2022-

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other