BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20287603 · Received September 23, 2024

    Report

    Report Number
    3014732157-2024-00691
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 26, 2024
    Report Date
    December 17, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    CASSETTES WERE RETURNED FOR EVALUATION. TO ASSESS THE LEAK, 4 CATEGORIES OF TEST WERE PERFORMED: 1) OBSERVATION OF THE WELD QUALITY UNDER MICROSCOPE, 2) FLOW ACCURACY TEST: 0.5 ML/HR FLOW ACCURACY TEST (2-HOUR DURATION) - SETUP AND PROCEDURE ACCORDING TO APPLICABLE WORK INSTRUCTION. 0.5 ML/HR IS THE LOWEST PROGRAMMABLE FLOW RATE OF THE LVP, UTILIZING THE HIGH DRIVE PRESSURE LOGIC OF THE LVP. THIS IS CONSIDERED WORST-CASE FOR TESTING THE EFFECTS OF LEAKS ON UNDER INFUSION DUE TO THE SMALLEST FLOW RATE WITH HIGHEST PRESSURE, 3) PRESSURIZED DYE TEST: WATER MIXED WITH GREEN DYE PRESSURIZED BY HAND AND INSERTED AT THE SECONDARY INLET TO CHECK FOR INTERNAL LEAKS AND 4) OBSERVATION OF THE WELD QUALITY UNDER MICROSCOPE AFTER DYE TEST: THIS TEST IS USED TO IDENTIFY ANY VISUAL LEAK CHANNELS IN THE WELD IF PRESENT. RESULTS FOUND: 1) OBSERVATION OF THE WELD QUALITY UNDER MICROSCOPE REVEALED A BULGE WELD SEEN AT PARTICULAR SECTIONS IN THE 6 CASSETTES PROVIDED. THE WELDING WAS LOCALIZED IN THE AREA ABOVE THE RESISTOR KNOB. THE WELDING DID NOT LOOK TO COVER THE FULL WALL WELDING THICKNESS AS IN THE OTHER WELDING AREAS. 2) FLOW ACCURACY TEST AT 0.5ML/HR WAS PERFORMED ON THE 6 ADMINS SET PROVIDED AND ALL PASSED. NO UNDER INFUSION FOUND. ADDITIONALLY, NO VISIBLE LEAKS, WITH NAKED EYE, WERE SEEN IN THE RESISTOR KNOB CAVITY AFTER THE TEST, 3) PRESSURIZED DYE TEST WAS PERFORMED ON THE 6 SETS AND NO LEAKS WERE GENERATED IN THE AREA WHERE BAD WELDING WAS IDENTIFIED IN TEST 1. AND NO VISIBLE LEAKS, WITH NAKED EYE WERE IDENTIFIED IN THE RESISTOR KNOB CAVITY, 4) OBSERVATION OF THE WELD QUALITY UNDER MICROSCOPE AFTER DYE TEST: 6 CASSETTES WERE TESTED UNDER PRESSURIZED DYE TEST AND VIEWED UNDER MICROSCOPE TO CHECK IF MICRO LEAKS COULD BE HIGHLIGHTED THROUGH GREEN CHANNEL PASSING THROUGH THE WELDING WALL. NO MICRO LEAKS WERE OBSERVED. WHILE THE WELDING LOOKED TO BE LOWER QUALITY, THE GREEN DYE DID NOT GO INSIDE THE WELDING NOR DID IT PASS THROUGH THE WELDING WALL. NO LEAK IDENTIFIED. LEAKS IDENTIFIED WITHIN THE CASSETTE WERE NOT GENERATING AN UNDER INFUSION ACCORDING TO THE TEST PERFORMED. NO WELD RELATED LEAKS WERE SEEN UNDER PRESSURIZED DYE TEST. THE TRUE ROOT CAUSE COULD NOT BE IDENTIFIED. THE MOST LIKELY POTENTIAL CAUSE OF THE ISSUE IS IDENTIFIED TO BE WELD QUALITY WHICH MIGHT HAVE RESULTED INTO A FEW DROPS OF INFUSATE (NOT ENOUGH TO CAUSE UNDERINFUSION) TO TRAVEL INSIDE THE RESISTOR KNOB CAVITY. HOWEVER, DURING THE TEST, THE TEST RESULTS DID NOT SHOW ADEQUATE EVIDENCE TO CONFIRM THE CAUSE NOR ANY ALARMS WERE TRIGGERED DURING THE TESTS. POTENTIAL CAUSE OF DEGRADED WELD QUALITY HAS BEEN ELIMINATED BY DISCONTINUING THE SUPPLIER. NO ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: 5 OF 6 ADMIN SETS REPLACED ON (B)(6) 2024 HAVE VISIBLE LEAKS INTO THE RESISTOR KNOB CAVITY. THIS WAS FIRST NOTICED DUE TO AIR IN LINE ALARMS. PHOTO ATTACHED. THE PUMPS WERE INFUSING RO WATER WITH 1/2 ML BLEACH AT 180 ML/HR WHEN THE ISSUE WAS NOTICED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: SET-0013 - VISIBLE LEAK INTO RESISTOR KNOB CAVITY AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290921 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 3010126 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown