BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM

    MDR report key: 17510012 · Received August 11, 2023

    Report

    Report Number
    3013508628-2023-00006
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 10, 2023
    Manufacturer
    IRRAS USA INC
    Product Code
    GWM
    PMA / PMN Number
    K222471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE COMPLAINT, IRRAS SENT THE CATHETER TO CG LABS FOR DECONTAMINATION. DECONTAMINATION WAS PERFORMED PER CG LABS SOP 82070-136 ON (B)(6) 2023. POST DECONTAMINATION, THE CATHETER WAS SHIPPED TO IRRAS AND HELD IN THE DECONTAMINATION ROOM; THE BILL OF LADING (BOL) IS ATTACHED TO THIS COMPLAINT (REFERENCE: COMPLAINT 188 DECONTAMINATION BOL). PICTURES TAKEN DURING THE INVESTIGATION ARE PROVIDED AS AN ATTACHMENT (REFERENCE: COMPLAINT (B)(4) PICTURES FROM INVESTIGATION 20230731.ZIP). THE CATHETER WAS OBSERVED POST DECONTAMINATION FROM CG LABS. THE CATHETER WAS CLEAN AND WITHOUT EVIDENCE OF BLOOD AND MATERIAL AND WAS INTACT. SUTURING REMAINED ON THE OUTER CATHETER BODY AT 15 CM (SHOWN IN PICTURES) AND TEGADERM ON THE CATHETER BODY JUST DISTAL THE BIFURCATION. A SYRINGE FILLED WITH 70% ALCOHOL WAS CONNECTED TO THE IRRIGATION 3-WAY FITTING'S FEMALE LUER AND THE CAP ON THE FEMALE LUER SIDE PORT WAS REMOVED AND THE DRAINAGE LUER INTERCONNECTED (A PICTURE OF THE SETUP IS PROVIDED WITHIN THE FILE ATTACHMENTS). ALCOHOL WAS INJECTED THROUGH THE IRRIGATION CHANNEL; 20% OF THE LIQUID REACHED THE END OF THE CATHETER, 80% LEAKED OUT OF THE PROXIMAL END OF THE BIFURCATION AT THE IRRIGATION TUBE BOND JOINT TO THE BIFURCATION. THE 3-WAY STOPCOCK WAS ROTATED TO TURN THE VALVE CLOSED TO THE IRRIGATION TUBING AND OPEN TO THE DRAINAGE CHANNEL; LIQUID FLOWED OUT OF THE CATHETER TIP.A HEMOSTAT WAS PLACED ON THE CATHETER DISTAL THE BIFURCATION AND THE IRRIGATION AND DRAINAGE CHANNELS INDEPENDENTLY PRESSURIZED WITH AIR; THERE WAS NO COMMUNICATION BETWEEN THE IRRIGATION AND DRAINAGE CHANNELS, THE DRAINAGE CHANNEL HELD PRESSURE, THE IRRIGATION CHANNEL WAS NOT ABLE TO HOLD PRESSURE.THE CATHETER HUB WAS SUBMERGED IN ALCOHOL AND THE SYRINGE USED TO PRESSURIZE THE CHANNELS USING AIR; AIR BUBBLES WERE FOUND TO EMIT AT THE INTERFACE OF THE IRRIGATION TUBE, GLUE JOINT, BIFURCATION HUB (A VIDEO PROVIDED IN THE FILE ATTACHMENT).VIDEO AND PICTURES WERE TAKEN OF THE LEAK. THE LEAK IS DUE TO A NON-UNIFORM BOND DUE TO INADEQUATE ADHESIVE OR CURING AND AIR BUBBLE ENTRAPMENT DURING THE BONDING PROCESS. A ROUND HOLE IS SEEN IN THE BOND SITE OF THE IRRIGATION TUBE TO BIFURCATION AND IS THE SITE OF THE LEAKAGE. DURING THE INVESTIGATION, THE LEAK RATE INDICATES THAT IF THE LEAK SIZE HAD EXISTED FROM THE START, DURING PRIMING OR ACTIVE FLUID EXCHANGE, IT WOULD HAVE BEEN DETECTED. THEREFORE, IT IS PROBABLE THAT THE LEAK EITHER DID NOT EXIST AT THE BEGINNING OF TREATMENT OR IT WORSENED GRADUALLY OVER THE COURSE OF 6-7 HOURS UNTIL IT WAS FINALLY DETECTED.THE BIFURCATION WAS SECTIONED, AND THE IRRIGATION CHANNEL WAS INSPECTED. THERE IS INDICATION THE TYGON TUBING BOND WAS NOT CONTINUOUS (SOME DELAMINATION OF TUBE FROM BIFURCATION). INSPECTION OF THE DRAINAGE CHANNEL (THAT DID NOT LEAK) SUGGEST ADHESIVE ENTERED 3-4 MM INTO THE POCKET AND WAS CURED. PICTURES ARE PROVIDED. A RISK ASSESSMENT WAS CONDUCTED. PER 500019 REVISION E RMF, RISK PLAN 8.6 POST-PRODUCTION ACTIVITIES, CUSTOMER COMPLAINTS ARE REVIEWED TO ENSURE THE RISK IS IDENTIFIED, INVESTIGATED TO ASSESS ACCEPTABILITY OF THE RESIDUAL RISK AND IMMEDIATE ACTION TAKEN TO ADDRESS UNACCEPTABLE RISKS. THE LIQUID LEAKAGE AT THE BOND JOINT BETWEEN THE IRRIGATION TUBE AND THE BIFURCATION DUE TO DESIGN AND MANUFACTURING PROCESS IS IDENTIFIED WITHIN THE FOLLOWING RISK MANAGEMENT DOCUMENTS (THE FAILURE IS NOT DUE TO THE FAILURE IN THE USE OF THE DEVICE): 1) 500026 REVISION D, DFMEA, LINE ITEMS 114, CATHETER ASSEMBLY #7000271, DEVICE LEAKAGE, COMPROMISED BOND: BIFURCATION TO TYGON TUBING IDENTIFIED AS A RISK CLASS 2. 2) 500050 REVISION D, PFMEA 12.7: BOND 02345 TO BIFURCATION HUB RESULTS IN A BROKEN DEVICE AND IDENTIFIED AS CLASS 1 RISK. 12.8: BOND 02345 TO BIFURCATION HUB RESULTS IN A BONDING DEFECT - BUBBLES, POOR FILLET, ETC AND IS AN AESTHETIC FAILURE ONLY IDENTIFIED AS RISK CLASS 0. AN OCCURRENCE OF 1 WAS ASSIGNED IN BOTH THE DFMEA AND PFMEA. THIS IS THE FIRST RECORDED OCCURRENCE OF THIS FAILURE; NO CHANGE IN THE ASSIGNED OCCURRENCE LEVEL IS RECOMMENDED. THE MANUFACTURING PROCESS REQUIRES A FINAL TEST TO VERIFY THE CATHETER DOES NOT LEAK; THE DMR FOR THE CATHETER REQUIRES THE FINAL TEST WAS CONDUCTED ON EACH CATHETER AND 100% VISUAL INSPECTION OF THE BOND JOINT.

    Description of Event or Problem · 0

    ON (B)(6) 2023 AT 1900 EST, IRRAFLOW TREATMENT WAS STARTED ON A 60 YEAR OLD FEMALE, AND NO LEAKAGE WAS DOCUMENTED DURING THE INITIAL PRIMING OF THE SYSTEM. AT 0200 ON THE FOLLOWING DAY, AFTER 6-7 HOURS OF ACTIVE FLUID EXCHANGE USE, IRRAFLOW WAS DISCONTINUED DUE TO CATHETER LEAKAGE AT THE BIFURCATION SITE. THE PATIENT HAD BEEN ADMITTED FOR HYPERTENSION. SHE WAS ADMITTED TO ICU WITH AN INTRAVENTRICULAR HEMORRHAGE. IRRAFLOW TREATMENT RESULTED IN A 90% REDUCTION IN DEMONSTRATED HYDROCEPHALUS PRIOR TO THE CATHETER LEAKAGE OCCURRENCE. AT 0700, THE NEUROSURGEON REMOVED THE IRRAFLOW CATHETER, AND DECIDED TO NOT INSERT A NEW CATHETER. THE PATIENT DID NOT REQUIRE A SHUNT AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT SUBSEQUENTLY IMPROVED WAS MOVED OUT OF ICU, AND WAS LATER DISCHARGED. THE HYDROCEPHALUS DUE TO INTRACRANIAL BLEED (IVH) AT ADMISSION HAD RESOLVED; HX OF HTN (NO OTHER COMORBIDITIES KNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869457 IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM IRRAFLOW CATHETER GWM IRRAS USA INC 2.0 1010342

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other