BEUDAMED
    FDA Adverse Event Death Summary report: N

    IRRAS

    MDR report key: 23106033 · Received September 21, 2025

    Report

    Report Number
    3013508628-2025-00001
    Event Type
    Death
    Date Received
    September 21, 2025
    Date of Event
    August 16, 2025
    Report Date
    September 17, 2025
    Manufacturer
    IRRAS USA, INC.
    Product Code
    JXG
    PMA / PMN Number
    K231664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRRAS HAS JUST RECEIVED NOTIFICATION OF THIS SERIOUS ADVERSE EVENT (DRUG-RESISTANT PSUEDOMONAS INFECTION) AND IS IN THE PROCESS OF COLLECTING DATA RELATED TO THE USE OF THE IRRAFLOW SYSTEM BY COTTAGE HEALTH. THE INITIAL REPORT FROM THE END USER STATES THAT THE INFECTION WAS DISCOVERED ON DAY 24 OF TREATMENT, BUT THE IRRAFLOW IS ONLY INDICATED FOR 5 DAYS OF USE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT BILATERAL TREATMENT WITH A SECOND, NON-IRRAFLOW DRAINAGE CATHETER PLACED ON THE CONTRALATERAL SIDE. IRRIGATION WAS PERFORMED USING AN UNKNOWN RINGER'S LACTATE SOLUTION. ADDITIONALLY, PATIENT WAS REPORTED TO BE AN IV DRUG ABUSER. THEREFORE, THE SOURCE OF THE INFECTION IS CURRENTLY UNKNOWN. THE END USER ALSO CONFIRMED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS CONFIRMED TO BE FREE OF INFECTION PRIOR TO WHEN THE FAMILY MADE THE DECISION TO TRANSITION TO COMFORT CARE, WHERE THE PATIENT EVENTUALLY PASSED. SPECIFIC DEVICE DETAILS HAVE NOT BEEN SUPPLIED BY THE END USER AND ARE UNKNOWN AT THIS TIME. HOWEVER, EVERY LOT OF IRRAFLOW CATHETERS IS E-BEAM STERILIZED, AND EACH LOT RECEIVES A STERILIZATION CERTIFICATE. ROUTINE STERILIZATION DOSE AUDITS ALL HAVE PASSING RESULTS WITH NO BIOBURDEN ISSUES. THIS IS AN INITIAL REPORT, AND IRRAS WILL FOLLOW UP AS INFORMATIVE DATA FROM THE INVESTIGATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IRRAS RECEIVED A COMPLAINT ON 09/17/2025 OF A PATIENT WHO HAD BEEN ADMINISTERED THERAPY USING THE IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM FOR 24 DAYS; TREATMENT HALTED DUE TO "CONTAMINATED IRRAFLOW INTRAVENTRICULAR DEVICE WITH NEW MDR PSEUDOMONAS SPECIES. WE HAVE IDENTIFIED A NEW SPECIES OF PSEUDOMONAS NOT YET NAMED ASSOCIATED TO AN INTRAVENTRICULAR DEVICE CAUSING BRAIN ABSCESS AND VENTRICULITIS ON A PATIENT. WE HAVE IDENTIFIED THIS NEW SPECIES OF BACTERIA VIA WHOLE GENOME SEQUENCING AND ONLY 2 CASES EVER REPORTED WORLDWIDE AT (B)(6) HOSPITAL IN CHICAGO. ALL ISOLATES WERE ISOLATED FROM CSF FROM PATIENTS AND THE ONLY THING IN COMMON IS THAT THEY ALL HAD THIS DEVICE IN PLACE AT THE TIME IF THE INFECTION. WE HIGHLY SUSPECT THERE IS A CONTAMINATION OF THESE DEVICES AND RECOMMEND AN INVESTIGATION. THIS IS A HIGHLY RESISTANT STRAIN OF BACTERIA RESISTANT TO 99% OF AVAILABLE ANTIBIOTICS." USE OF THE IRRAFLOW CATHETER AND TUBE SET ARE ONLY INDICATED FOR LESS THAN OR EQUAL TO 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081903 IRRAS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG IRRAS USA, INC. ICGS 020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death| L| O