BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW SYSTEM TUBE SET CASSETTE

    MDR report key: 16619022 · Received March 27, 2023

    Report

    Report Number
    3013508628-2023-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 14, 2023
    Manufacturer
    IRRAS USA INC.
    Product Code
    GWM
    PMA / PMN Number
    K222471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    IRRAS COMPLAINT NO. 150 AND 152, SAME DEVICE, SAME PATIENT- RE IRRAFLOW TUBE SET/CASSETTE: PATIENT HAD AIR IN IRRIGATION LINE, PAST CASSETTE. NURSE PRACTITIONER DID A MANUAL FLUSH OF THE IRRIGATION LINE. THERE HADN'T BEEN AN AIR BUBBLE ALARM PRECEDING THE AIR BEING NOTED. PATIENT WAS IN IRRIGATION MODE WITH RATE OF 120 ML/HR. PER HOSPITAL STAFF, THERE WERE A FEW BUBBLES APPROXIMATELY A FEW CENTIMETERS IN LENGTH THAT THEY WERE CONCERNED ABOUT. THIS ISSUE OCCURRED WHILE TREATING A 67 YEAR OLD FEMALE PATIENT FOR INTRAVENTRICULAR HEMORRHAGE ( IVH), RESULTING IN A TREATMENT DELAY OF APPROXIMATELY 1 HOUR. LATER THAT DAY, ANOTHER ISSUE AROSE WITH THE SAME TUBE SET. PATIENT IN DRAINAGE MODE, NOT DRAINING. WHILE TROUBLE SHOOTING THE SITUATION IT WAS NOTED THAT THE ROLLER CLAMP ON THE DRAINAGE LINE WAS IN THE OPEN POSITION, BUT STUCK IN PLACE AND ALSO WAS PINCHED OFF, IMPEDING FLOW. WHILE MANIPULATING THE ROLLER CLAMP TO FIX IT THE BALL ON THE ROLLER CLAMP POPPED OFF. THIS ISSUE CREATED ADDITIONAL DELAY IN TREATMENT. WHEN THE ROLLER CLAMP, WHICH IS A SECONDARY MEASURE FOR TURNING OFF IRIGATION FLOW, WAS NO LONGER ATTACHED, THE TUBE SET WORKED PROPERLY, AND WAS NOT REQUIRED TO BE REPLACED. THIS FOLLOW UP REPORT IS BEING PROVIDED TO INCLUDE THE RESULTS OF THE IRRAS COMPLAINT INVESTIGATION: THE TUBE SET, LOT # 1009748 WAS SHIPPED FROM CDH VIA RMA23-021 TO A CONTRACTED DECONTAMINATION FACILITY, AND THEN SHIPPED TO IRRAS SOUTH WHERE IT WAS RECEIVED ON 03/20/2023.THE TUBE SET WAS INSPECTED FOR ANY DAMAGE. THE ROLLER CLAMP WAS INSPECTED. IT WAS NOTED THAT THE ROLLER WAS MISSING, AS REPORTED BY THE CUSTOMER. THE TUBING WAS INSPECTED AND FOUND TO BE DEFORMED AT THE ROLLER POSITION. THE DRAINAGE TUBING IS SPECIFIED TO HAVE AN OD OF 5.56MM; THE DEFORMED PORTION OF THE TUBING WAS MEASURED AND THE OD WAS 3.07MM. A CHECK VALVE WITH A SPECIFIED CRACKING PRESSURE OF 1.5 - 5PSI IS LOCATED ON THE IRRIGATION LINE OF THE CASSETTE BETWEEN THE IRRIGATION BAG SPIKE AND THE CASSETTE TO PREVENT FREE FLOW OF IRRIGATION FLUID THROUGH THE CASSETTES TUBING. THE HEAD PRESSURE OF A FULL IRRIGATION BAG (1000ML) WITH A FULLY EXTENDED IRRIGATION TUBING WAS MEASURED TO BE 1.15PSI. THEREFORE, THE CRACKING PRESSURE OF THE SPECIFIED CHECK VALVE IS OVERQUALIFIED FOR THIS USE CASE, CAUSING TURBULENT FLOW IN THE TUBING DISTAL TO THE CHECK VALVE LEADING TO THE IRRIGATION LINE AIR BUBBLES AND TUBING COLLAPSE. THE WIDE CRACK PRESSURE RANGE OF THE SPECIFIED CHECK VALVE CAN ATTRIBUTE TO WHY THIS FAILURE IS INTERMITTENT DURING FIELD USE. THE INVESTIGATION RESULTS CONFIRMED THE BROKEN ROLLER CLAMP ISSUE WAS DUE TO USE ERROR, HAVING USED THE TUBE SET LONGER THAN THE REQUIRED 5 DAYS, CAUSING DEFORMATION OF THE TUBING WHICH MAY HAVE CONTRIBUTED TO THE IMPEDANCE OF THE DRAINAGE FLOW. THE ROLLER CLAMP MAY HAVE HAD EXCESSIVE FORCE APPLIED TO IT BY THE NURSE, AND COMBINED WITH THE DEFORMED TUBING, ALLOWED IT TO DISENGAGE (POP OFF) MORE EASILY. THE IDENTIFIED ROOT CAUSE OF THE AIR IN LINE IS RELATED TO THE CHECK VALVE LOCATED BETWEEN THE SPIKE AND CASSETTE ON THE IRRIGATION LINE. CHECK VALVES WITH HIGH CRACKING PRESSURES WERE SHOWN TO DEVELOP SMALL BUBBLES DISTAL TO THE CHECK VALVE LEADING TO LARGE BUBBLE FORMATION IN THE TUBING DISTAL TO THE CASSETTE. THE ASSOCIATED DOCUMENTS WILL BE INCLUDED IN THE COMPLAINT PROCESS AS PART OF THE DOCUMENTED ACTIVITY FOR THE INVESTIGATION. THE INVESTIGATION AND FUNCTIONAL TESTING CONFIRMED THAT THE ROLLER CLAMP ISSUE IS ATTRIBUTED TO USE ERROR ALONG WITH CLINICAL USE OF THE TUBE SET BEYOND ITS INTENDED USE BOTH OF WHICH CONTRIBUTED TO THE CUSTOMER EXPERIENCE AS DOCUMENTED IN THE COMPLAINT. A REVIEW OF THE LOT HISTORY RECORD (LHR) OF THE TUBE SET, 1009748, SHOWS THAT: O THE TUBE SET WAS ASSEMBLED ACCORDING TO IRRAS' APPROVED CONTRACT MANUFACTURER (CM) SECOND SOURCE MEDICAL (SSM) VALIDATED MANUFACTURING PROCESSES. O NO MANUFACTURING NONCONFORMANCES WERE IDENTIFIED IT IS IRRAS' ASSESSMENT THAT THE TUBE SET WAS FUNCTIONING AS INTENDED AT THE TIME OF TREATMENT.

    Description of Event or Problem · 0

    IRRAS COMPLAINT NO. (B)(4), SAME DEVICE, SAME PATIENT- RE IRRAFLOW TUBE SET/CASSETTE: PATIENT HAD AIR IN IRRIGATION LINE, PAST CASSETTE. NURSE PRACTITIONER DID A MANUAL FLUSH OF THE IRRIGATION LINE. THERE HADN'T BEEN AN AIR BUBBLE ALARM PRECEDING THE AIR BEING NOTED. PATIENT WAS IN IRRIGATION MODE WITH RATE OF 120 ML/HR. PER HOSPITAL STAFF, THERE WERE A FEW BUBBLES APPROXIMATELY A FEW CENTIMETERS IN LENGTH THAT THEY WERE CONCERNED ABOUT. THIS ISSUE OCCURRED WHILE TREATING A 67 YEAR OLD FEMALE PATIENT FOR INTRAVENTRICULAR HEMORRHAGE ( IVH), RESULTING IN A TREATMENT DELAY OF APPROXIMATELY 1 HOUR. LATER THAT DAY, ANOTHER ISSUE AROSE WITH THE SAME TUBE SET. PATIENT IN DRAINAGE MODE, NOT DRAINING. WHILE TROUBLE SHOOTING THE SITUATION IT WAS NOTED THAT THE ROLLER CLAMP ON THE DRAINAGE LINE WAS IN THE OPEN POSITION, BUT STUCK IN PLACE AND ALSO WAS PINCHED OFF, IMPEDING FLOW. WHILE MANIPULATING THE ROLLER CLAMP TO FIX IT THE BALL ON THE ROLLER CLAMP POPPED OFF. THIS ISSUE CREATED ADDITIONAL DELAY IN TREATMENT. WHEN THE ROLLER CLAMP, WHICH IS A SECONDARY MEASURE FOR TURNING OFF IRRIGATION FLOW, WAS NO LONGER ATTACHED, THE TUBE SET WORKED PROPERLY, AND WAS NOT REQUIRED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597451 IRRAFLOW SYSTEM TUBE SET CASSETTE INTRACRANIAL PRESSURE MONITOR GWM IRRAS USA INC. 2.0 1009748

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other