BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20303002 · Received September 25, 2024

    Report

    Report Number
    3014732157-2024-00696
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 26, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030214
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: PLEASE SEE BELOW INCIDENT REPORT INFORMATION FROM A SECONDARY PORT FAILURE THAT RESULTED IN HAZARDOUS DRUG SPILL YESTERDAY, (B)(6) 24. NURSE WAS NOT WEARING PPE. ASSUMED LOT NUMBER IN IMAGE BELOW. SET NOT SAVED SINCE CONTAMINATED WITH HAZARDOUS DRUG. "THE INVENIX LVP PRIMARY INFUSION SET BROKE OFF AT THE SECONDARY PORT LOCATED AT THE CASSETTE WHEN UNCLAMPING THE PUMP LEVER TO TROUBLE SHOOT THE "AIR IN LINE" ALERT. PER HELPING RN, ONCE THE LEVER UNCLAMPED THE SECONDARY TUBING "POPPED OFF" SHOOTING SOME CHEMO IN THE AIR AND DRIPPING ON THE GROUND. ALL TUBING WAS CLAMPED AND PACLITAXEL BROUGHT TO PHARMACY TO RE-TUBE, CHANGED PRIMARY LINE TO NEW NS FLUIDS, AND BROUGHT MALFUNCTIONED TUBING TO PHARMACY MANAGER. NO CHEMO ON PATIENT OR SURROUNDING PATIENT. CHEMO SPILL APPEARS TO BE < 100 ML. CLEANED AREA WITH TOWEL AND SANI-CLOTH INCLUDING THE PUMP." ADDITIONALLY REPORTED: POTENTIAL UNDERDOSING DUE TO INABILITY TO MEASURE AMOUNT LEAKED, IS THE ONLY PATIENT IMPACT PROVIDED BY THE NURSES. NO CONFIRMED STAFF HARM HOWEVER GIVEN THAT THE EMPLOYEE WAS NOT WEARING PPE AND SPLASHING WAS NOTED, EXPOSURE CANNOT BE RULED OUT. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: BROKEN SECONDARY PORT UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. A PICTURE WAS RETURNED BY THE CUSTOMER. PER THE RETURNED PICTURE, THE LUER ACTIVATED VALVE WAS BROKEN AT THE SECONDARY PORT LOCATED AT THE CASSETTE. THE CUSTOMER COMPLAINT IS CONFIRMED. THE PROBABLE ROOT CAUSE COULD BE RELATED TO AN INCORRECT USE OF THE TORQUE METER USED FOR THE ASSEMBLY OF THE LUER ACTIVATED VALVE. THE ASSOCIATE MAY HAVE EXCEEDED THE FORCE APPLIED TO THE DEVICE BECAUSE THE TORQUE WRENCH DOES NOT PREVENT THE ASSOCIATE FROM EXCEEDING SAID FORCE AT THE TIME OF ASSEMBLY. CURRENT CONTROLS RELATED TO THIS DEFECT INCLUDE 1) MANUFACTURING 100% LEAK TEST WITH 22.5 PSI FOR APPROXIMATELY 5 SECONDS, 2) QUALITY VISUAL INSPECTION, 3) QUALITY UNDERWATER LEAK TEST WITH 22.5 PSI FOR 10 SECONDS. CORRECTIVE ACTION: 1) IMPLEMENTING A CHANGE / VALIDATION OF NEW TORQUE WRENCH, 2) UPDATE OF RISK DOCUMENT IN ORDER TO ADDRESS THIS DEFECT. A BATCH REVIEW WAS PERFORMED. AN INTERNAL INVESTIGATION WAS GENERATED RELATED TO STRESS MARKS IN SECONDARY PORT OF IVENIX CASSETTE. AFTER REINSPECTION, FINISHED GOOD LOT PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR QUALITY TESTING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234466 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA LLC SET-0032-01 FA23L07376 00811505030214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown