BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 19906861 · Received August 5, 2024

    Report

    Report Number
    3014732157-2024-00534
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 16, 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
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D UPDATED TO ALIGN WITH THE INFORMATION LISTED ON GUDID.

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    ONE SAMPLE (LOT#FA23E08302) WAS EVALUATED ON 17JUL2024 TO REPLICATE THE ISSUES OBSERVED BY THE CUSTOMER. THE PROBLEM WAS REPRODUCED. A DYE TEST WAS PERFORMED ON THIS 1 SAMPLE TO CONFIRM THE LOCATION OF LEAK. IT WAS REPORTED AS A LEAK WITH A RELOAD CASSETTE MESSAGE. DURING EVALUATION, IT WAS NOTICED THAT THE LEAK WAS OCCURRING AT THE SECONDARY INLET VALVE LEADING TO A LEAK AT THE WELD2 VENT HOLE. THE MOST LIKELY ROOT CAUSE IS MISPLACED OR DISPLACED DIAPHRAGM CONFIRMED WHEN LOOKED UNDER MAGNIFICATION. THE BATCH RECORDS FOR LOT FA23E08302 WERE REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. A SUPPLIER COMPLAINT WAS ISSUED FOR 1 SAMPLE. CUSTOMER REPORTED (LOT#3009780) LEAK NEAR PRIMARY PORT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR REVIEW. BASED ON THE CUSTOMER PROVIDED PHOTO, THE COMPLAINT COULD NOT BE CONFIRMED. A TRACEABILITY WAS PERFORMED FOR THE MOLDED COMPONENTS THAT WERE USED TO MAKE THE FINISHED LOT 3009780. A DHR REVIEW OF THE RELATED LOTS FOUND NO RELATED NONCONFORMANCES. A REVIEW OF ALL RAW MATERIAL WAS CONDUCTED AND NO ISSUES WERE NOTED. ALL PRODUCT RAN AT VALIDATED PARAMETERS. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE FINISHED LOT 3009780 ALSO FOUND NO RELATED NONCONFORMANCES. THE DEVICE WAS WELDED WITHIN THE VALIDATED PARAMETERS AND PASSED ALL QA INSPECTIONS. THE LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SITE (P/N SET-0013-1) IS 100% DRY LEAK TESTED TO THE METHOD AND PARAMETERS DEFINED BY FRESENIUS KABI. HOWEVER, AS COMMUNICATED BY FRESENIUS KABI FOLLOWING A PREVIOUS COMPLAINT, THE TEST IS NOT CAPABLE OF DETECTING ALL LEAKS. A NEW DRY LEAK TEST IS CURRENTLY UNDER DEVELOPMENT BY FRESENIUS KABI TO PREVENT FUTURE OCCURRENCES, ALTHOUGH THE LEAK ASSOCIATED WITH THIS COMPLAINT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. THE FOLLOWING CORRECTIVE ACTIONS WERE PERFORMED: 1) DEVELOP A NEW FRESENIUS KABI DRY LEAK TEST AND 2) A QUALITY ALERT WAS ISSUED TO THE PRODUCTION FLOOR AND AWARENESS TRAINING WITH THE OPERATORS WAS PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: STAFF REPORTED: WE HAVE ALSO RECEIVED A COUPLE OF REPORTS THAT CASSETTES HAVE BEEN LEAKING FROM THE AREA CIRCLED BELOW. STAFF HAVE BEEN INSTRUCTED TO SAVE TUBING AND REPORT THIS OUT DURING SHIFT AND HOUSEWIDE SAFETY HUDDLES. WAITING FOR CONFIRMATION OF SET TYPE, THAT THERE WAS NO PATIENT HARM AND NO REPORTS OF ISSUES STOPPING ACTIVE INFUSION. INFUSION WAS STOPPED AND TUBING REPLACED. ADDITIONAL INFO REPORTED BY STAFF: HERE IS SOME ADDITIONAL INFORMATION THAT WAS PROVIDED TO THE CLINICAL ENGINEERING TEAM IN THE WORK ORDER: 1. PATIENT WAS HOOKED UP TO NORMAL SALINE TO INITIATE INFUSION. 2. WHEN CASSETTE WAS PLACED INTO THE PUMP AND TUBING CONNECTED TO THE PATIENT, THE USER RECEIVED "RELOAD CASSETTE" MESSAGE ON THE SCREEN OF THE PUMP. 3. RN OBSERVED SALINE RUNNING FROM BEHIND CASSETTE DOWN THE TUBE. THIS WAS LEFT IN PLACE TO BEGIN PRIMING A NEW LINE. 4. RN NOTICED THAT THE 250 ML BAG OF SALINE WAS EMPTY. 5. REPORTS OF SOME ON THE FLOOR AND NURSE IS ASSUMING THAT THE REST WENT INTO THE PATIENT DESPITE THE DIAL BEING CLOSED ON THE CASSETTE. IMPORTANT THINGS TO NOTE! · SALINE BAG WAS THE PRIMARY LINE AND THERE WAS NO SECONDARY TUBING CONNECTED. · PUMP WAS NOT PROGRAMMED TO INFUSE WHILE WHEY WERE PRIMING THE NEW TUBING. · CASSETTE DOOR WAS CLOSED. · THE AMOUNT ON THE FLOOR DID NOT APPEAR TO BE A QUANTITY OF 250 ML. BIOME ALSO REPORTED LOT # OF ADMIN SET A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: SET-0013 - SET LEAK FROM CASSETTE. AN ACTIVE INFUSION DID STOP. 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
    2274806 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown