BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW SYSTEM

    MDR report key: 16671126 · Received April 3, 2023

    Report

    Report Number
    3013508628-2023-00002
    Event Type
    Malfunction
    Date Received
    April 3, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS ISSUE OCCURRED WHILE TREATING A 47 YEAR OLD FEMALE PATIENT FOR IVH. PATIENT IRRAFLOW CONTROL UNIT WAS ALARMING FOR A HIGH ICP AND NOT DRAINING. THE NURSE WAS TROUBLE SHOOTING THE SITUATION AND NOTED THAT ROLLER CLAMP ON THE DRAINAGE LINE WAS IN THE OPEN POSITION-BUT STICKING IN PLACE AND NOT OPEN ALL THE WAY-IMPEDING FLOW. WHEN SHE TRIED TO FIX ROLLER CLAMP THE ROLLER ON THE CLAMP, AND THEN POPPED OFF. THE TUBING DRAINAGE THEN FLOWED, BRINGING DOWN THE ICP, HOWEVER THE TUBING CLAMP ISSUE ALSO CREATED A MINOR DELAY IN TREATMENT. NO FURTHER INFORMATION WAS PROVIDED EXCEPT THAT THE REMAINING TREATEMENT WAS UNEVENTFUL. PRODUCT RETURN HAS BEEN REQUESTED. THIS FOLLOW UP REPORT IS BEING MADE TO PROVIDE THE RESULTS OF THE IRRAS COMPLAINT INVESTIGATION: THE TUBE SET, LOT # 1009748 WAS SHIPPED FROM CDH VIA RMA23-022 TO A CONTRACTED DECONTAMINATION FACILITY, AND THEN SHIPPED TO IRRAS SOUTH WHERE IT WAS RECEIVED ON 03/23/2023. 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 4.48MM. THE INVESTIGATION RESULTS CONFIRMED THE COMPLAINT 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 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

    THIS ISSUE OCCURRED WHILE TREATING A 47 YEAR OLD FEMALE PATIENT FOR IVH. PATIENT IRRAFLOW CONTROL UNIT WAS ALARMING FOR A HIGH ICP AND NOT DRAINING. THE NURSE WAS TROUBLE SHOOTING THE SITUATION AND NOTED THAT ROLLER CLAMP ON THE DRAINAGE LINE WAS IN THE OPEN POSITION-BUT STICKING IN PLACE AND NOT OPEN ALL THE WAY-IMPEDING FLOW. WHEN SHE TRIED TO FIX ROLLER CLAMP THE ROLLER ON THE CLAMP, AND THEN POPPED OFF. THE TUBING DRAINAGE THEN FLOWED, BRINGING DOWN THE ICP, HOWEVER THE TUBING CLAMP ISSUE ALSO CREATED A MINOR DELAY IN TREATMENT. NO FURTHER INFORMATION WAS PROVIDED EXCEPT THAT THE REMAINING TREATMENT WAS UNEVENTFUL. PRODUCT RETURN HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878412 IRRAFLOW SYSTEM TUBING GWM IRRAS USA INC. TUBE SET 2.0 1009748

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other