BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVENIX, INC.

    MDR report key: 19953335 · Received August 9, 2024

    Report

    Report Number
    3014732157-2024-00562
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 27, 2024
    Report Date
    October 17, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Removal / Correction Number
    3014732157-08/02/24-001-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO PRODUCT WAS RETURNED. A CAPA WAS OPENED TO INVESTIGATE THE OVERINFUSION ALARMS AND A MANUFACTURING DEFECT FOR A SINGLE LOT WAS IDENTIFIED WHICH ALLOWED AN INTERNAL LEAK FROM ONE PORTION OF THE FLUID PATH TO ANOTHER. THE LOCATION OF THE LEAK BYPASSES THE FLUIDIC RESISTOR, AND THEREFORE THE "FLOW DIAL" IS UNABLE TO STOP THE FLOW OF FLUID WHEN OUTSIDE OF THE PUMP. THE LEAK RESULTS IN THE PUMP DECLARING ONE OF THE FOLLOWING 2 ALARMS: A) A "PUMP PROBLEM" FAIL-STOP ALARM (DUE TO OVER-INFUSION DETECTED BY CONTROL SYSTEM DURING INFUSION) B) A "TUBING SET PROBLEM" FAIL-STOP ALARM (DUE TO A LEAK DETECTED BY CONTROL SYSTEM DURING INFUSION) WHEN THE PUMP PROBLEM ALARM IS DECLARED, THE USER IS PROMPTED TO REMOVE THE ADMINISTRATION SET. IF THE USER EJECTS THE SET WITHOUT A SLIDE CLAMP ENGAGED THE LEAKAGE WILL CONTINUE. IF THE SET IS CONNECTED TO A PATIENT AT THE TIME, THE INFUSATE WILL CONTINUE TO BE DELIVERED TO THE PATIENT. THE INVESTIGATION WAS ABLE TO CONFIRM THAT A SINGLE LOT WAS AFFECTED DUE TO THIS MANUFACTURING DEFECT AS THE NEST ALIGNMENT ISSUE WAS ADDRESSED BEFORE THE PRODUCTION START OF THE NEXT LOT. THE MOST LIKELY ROOT CAUSE IDENTIFIED IS: INADEQUATE NEST LEVELING INSTALLATION CARRIED OUT AT CONTRACT MANUFACTURING SITE WHICH RESULTED IN A DEGRADED WELD QUALITY. ACTION PLANS HAVE BEEN DEVELOPED TO ENSURE PROPER NEST ALIGNMENT AND VERIFICATION VIA PROCEDURAL AND RMF UPDATES, TRAINING AND UPDATED LEAK TESTS.

    Description of Event or Problem · 0

    REPORTED TO FRESENIUS KABI: "ENTIRE BAG OF FENTANYL INFUSED INTO THE PATIENT" (TUBING SET PROBLEM). THEY HAD INITIALLY CHANGED PUMPS AND IT ALARMED AGAIN ON THE NEW ONE. THEY ALSO GOT AN AIL ALARM SO THEY THEN SAW THE BAG WAS EMPTY. FENTANYL 2500MCG/50ML INFUSING AT 75 MCG/HR. THEY HAD JUST HUNG A NEW BAG SO SHE KNEW SOMETHING WASN'T RIGHT. I ASKED IF SHE USED THE SLIDE CLAMPS WHEN REMOVING THE SET AND SHE DID NOT CLAIM TO AND SHE SAID THE "FLOW DIAL WAS CLOSED' WHEN THEY CHANGED IT OVER TO THE NEW PUMP. SHE SAID THE TOTAL SHOWED 11ML BUT IT SHOULD HAVE BEEN <2ML APPROXIMATELY SO SHE WAS SAYING THE TOTAL WAS NOT "RIGHT'. IT OCCURRED A LITTLE BEFORE 12:00 NOON TODAY. PATIENT HARM: PATIENT WENT INTO SEVERE BRADYCARDIA REQUIRING A TRANSVENOUS PACER (LIFE-SAVING INTERVENTION) AND VASOPRESSOR MEDICATIONS WERE STARTED. TUBING SAVED SET0013 AND LOT #3010538 ISSUE OCCURRED WHILE USING LVP-0004 SERIAL# (B)(6). PER NURSING LEADERSHIP AT (B)(6) ON 07-AUG-2024: - VP, PATIENT CARE SERVICES / CNE AT (B)(6) (MSA, RN, CPHQ) - DIRECTOR, NURSING ADMINISTRATION (RN, BSN, MHA) ON AUGUST 5TH, [VP, PATIENT CARE SERVICES] SHARED THAT THERE WAS NO CORRELATION BETWEEN THE OVER INFUSION REPORTED ON (B)(6) AND THE PATIENT'S EXPIRATION ON (B)(6). THE PATIENT'S CONDITION WAS POOR UPON ADMISSION AND WAS NOT EXPECTED TO LIVE. THE OVER INFUSION WAS A SETBACK HOWEVER, IT DID NOT CONTRIBUTE TO THE DEATH. NOTE - THIS MDR IS FOR THE 2ND PUMP THAT THE FACILITY TRIED TO USE WITH THE SAME SETUP AFTER ENCOUNTERING THE ALARM ON THE ORIGINAL PUMP. FRESENIUS KABI PERFORMED A PRELIMINARY REVIEW OF THE DEVICE LOGS, WHICH INDICATES THE FOLLOWING: OVERINFUSION CONDITION (TUBING SET PROBLEM) (SET ISSUE). - LOG ANALYSIS SHOWS THAT TWO TUBING SET PROBLEM ALARMS WERE TRIGGERED WHEN THE LVP RECOGNIZED THAT THE FLOWRATE WAS FASTER THAN EXPECTED. - THE SET WAS REMOVED AND RE-INSERTED TO CLEAR THE FIRST ALARM, BUT THE CONDITIONS PERSISTED, TRIGGERING A SECOND TUBING SET PROBLEM ALARM. - PER THE DESCRIPTION PROVIDED, THE ADMIN SET WAS TRANSFERRED TO A SECOND PUMP - NO PRODUCT RETURN REQUESTED, AS TUBING SET CONTAINED FENTANYL. FRESENIUS KABI PERSONNEL WENT ON-SITE TO THE CUSTOMER AND CONFIRMED THE ISSUE WITH THE SET THAT WAS BEING USED, HOWEVER THE CUSTOMER WOULD NOT ALLOW THE SET TO LEAVE THEIR PREMISES. FRESENIUS KABI HAS AN ACTIVE INVESTIGATION OPENED TO REVIEW THE ISSUE WHICH WAS FURTHER ESCALATED BY RECALLING A SINGLE IDENTIFIED LOT # OF THE ADMINISTRATION SET, WHICH WAS REPORTED TO THE FDA VIA A FIELD CORRECTIVE ACTION ON AUGUST 2, 2024. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515806 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 3010538 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention