BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRAFLOW

    MDR report key: 17765538 · Received September 18, 2023

    Report

    Report Number
    3013508628-2023-00007
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 16, 2023
    Manufacturer
    IRRAS USA INC.
    Product Code
    JXG
    PMA / PMN Number
    222471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION: THE CATHETER LOT NUMBER WAS NOT RETAINED, AND THE CATHETER WAS DISCARDED AFTER USE AND THEREFORE NOT RETURNED TO IRRAS. TO INVESTIGATE THE COMPLAINT 190, ALL LOTS SENT TO MOUNT SINAI WEST WITH RELEVANT EXPIRATION DATES WERE INVESTIGATED. THE FOLLOWING LHRS WERE REVIEWED FOR CONFORMITY WITH IRRAS APPROVED PACKAGING AND STERILIZATION METHODS: - LHR 1010358. - LHR 1010102. - LHR 1010342. - LHR 1009896. STERILIZATION RECORDS FOR THE LOTS LISTED ABOVE ARE IN CONFORMANCE WITH IRRAS STANDARDS, PRODUCT WAS E-BEAM STERILIZED PER THE VALIDATED VD MAX 27.5 METHOD. STERILIZATION WAS CONDUCTED AT APPROVED SUPPLIER STERIGENICS AND RUNS WERE WITHIN SPEC AND PASSED MINIMUM AND MAXIMUM DOSE TEST. BACTERIAL ENDOTOXIN TEST REPORTS WERE REVIEWED. ALL TESTING WAS CONDUCTED IN ACCORDANCE WITH ANSI/AAMI ST72:2019 AND TEST WAS PERFORMED IN COMPLIANCE WITH US FDA GMP REGULATIONS 21 CFR PARTS 210, 211 AND 820. THE KINETIC TURBIDIMETRIC RESULTS WERE WITHIN ACCEPTABLE RANGE FOR MEDICAL DEVICES IN CONTACT WITH CEREBROSPINAL FLUID, NOT MORE THAN 2.15 EU/DEVICE. PER IRRAS GUIDELINES, QUARTERLY DOSE AUDIT AND BIOBURDEN MONITORING WAS CONDUCTED FOR THE MANUFACTURING DATES ON THE LOTS LISTED ABOVE (Q1 - Q3 OF 2022). REPORTS WERE REVIEWED AND ARE IN CONFORMANCE AND PASS COMPANY/INDUSTRY STANDARDS. FURTHERMORE, REVIEW OF COMPLAINTS FROM (B)(6) 2021 TO (B)(6) 2023 SHOW ONLY ONE OTHER REPORTED CASE OF INFECTION, WHERE THE ROOT CAUSE WAS UNKNOWN. THE IDENTIFIED LOT NUMBERS HAVE BEEN FULLY DISTRIBUTED FROM IRRAS INVENTORY WITH NO OTHER REPORTS OF INFECTION TIED TO THESE LOT NUMBERS. INVESTIGATION SUMMARY: THE INVESTIGATION RESULTS CONFIRMED THAT THE CATHETER WAS MANUFACTURED AND STERILIZED IN ACCORDANCE WITH COMPANY STANDARD. THE ROOT CAUSE OF THE INFECTION AT THE INSERTION SITE IS UNABLE TO BE DETERMINED. IN LIGHT OF THE MANUFACTURING, STERILIZATION AND COMPLAINT HISTORY REVIEW, THE COMPLAINT RATE FOR CATHETER-ASSOCIATED INFECTIONS WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF TRENDS WITH A HEIGHTENED AWARENESS FOR TECHNIQUE AND USABILITY REPORTS. THESE MAY BETTER DESCRIBE THE LIKELY INTRODUCTION OF INFECTIOUS AGENTS. INVESTIGATION CONCLUSION: THE INVESTIGATION AND REVIEW OF THE PROBABLE LOT HISTORY RECORDS (LHR) OF THE CATHETER, 1010358, 1010102, 1010342, AND 1009896 CONFIRM THAT: THE CATHETER WAS ASSEMBLED AND PACKAGED ACCORDING TO IRRAS' APPROVED. CONTRACT MANUFACTURER (CM) ROSE MEDICAL VALIDATED MANUFACTURING PROCESSES. THE CATHETER WAS STERILIZED ACCORDING TO IRRAS' APPROVED STERILIZATION METHODS. BIOBURDEN TESTING WAS CONDUCTED AND PASSED ACCEPTABLE LIMITS. ROUTINE QUARTERLY DOSE AUDITS AND BIOBURDEN TESTING WERE CONDUCTED AND APPROVED. IT IS IRRAS' ASSESSMENT THAT THE SOURCE OF THE INFECTION IS UNABLE TO BE DETERMINED. RECORDS INDICATE THE CATHETER USED MET MANUFACTURING AND STERILIZATION ACCEPTANCE REQUIREMENTS.

    Description of Event or Problem · 0

    THE PATIENT, A 53 YEAR OLD FEMALE, ORIGINALLY PRESENTED WITH ICH AND RIGHT VENTRICULAR EXTENSION, AND A HISTORY OF HTN AFTER 15 DAYS OF IRRAFLOW TREATMENT, PATIENT DEVELOPED A LOW GRADE FEVER AND WAS DIAGNOSED WITH VENTRICULITIS; THE IRRAFLOW CATHETER WAS REMOVED, AND A ANTIBIOTIC IMPREGNATED DECI-SEAL EVD WAS PLACED VIA A DIFFERENT INSERTION SITE. THE PATIENT RECEIVED AND RESPONDED WELL TO INTRAVENOUS CEPHALOSPORIN ANTIBIOTIC TREATMENT. THE CSF WAS CULTURED AND CAME BACK POSITIVE FOR GRAM POSITIVE NON-SPECIFIED BACTERIA. RESIDENT PHYSICIAN PROVIDING CARE INDICATED THAT THE LIKELY SOURCE OF CSF CONTAMINATION WAS THE INSERTION SITE OF THE IF CATHETER. THE PATIENT WAS REPORTED TO BE RESPONDING WELL TO THE IV ANTIBIOTIC TREATMENT. THE IRRAFLOW CATHETER USED ON THE PATIENT WAS DISCARDED AND THEREFORE IS NOT AVAILABLE TO BE RETURNED. (B)(6) 2023: IRRAS NURSE EDUCATOR ALEX LEV REPORTED THAT TREATMENT WITH IRRAFLOW WAS SUBSEQUENTLY RESTARTED CONTRALATERALLY (ON LEFT) AND PHYSICIAN IS INSTILLING ANTIBIOTICS THRU THE CATHETER; THE EVD PLACED ON THE RIGHT AFTER IF DISCONTINUED IS STILL IN PLACE; THE PATIENT'S CONDITION IS IMPROVING-RESPONDING WELL TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268161 IRRAFLOW CATHETER JXG IRRAS USA INC. V. 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other