BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVP PRIMARY ADMIN SET 2 INLET

    MDR report key: 18288539 · Received December 7, 2023

    Report

    Report Number
    3014732157-2023-00206
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 7, 2023
    Report Date
    August 21, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EVALUATION STEPS PERFORMED: 1. VISUAL INSPECTION. 2. INSTALLED THE KIT ON IVENIX INFUSION SYSTEM MACHINE AND RAN THE PRIMING PROCESS. 3. UNDERWATER LEAK TEST. 255 SAMPLES PACKED WERE RETURNED FOR EVALUATION IN 11 BOXES. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE ASSEMBLIES OF THE KIT WERE ACCORDING TO THE DRAWING. A SLIT WAS OBSERVED VISIBLE AT THE LUER ACTIVATED VALVE, STRAIGHT (SECONDARY PORT). THE SAMPLE COMPLETED THE PRIMARY BOLUS PRIME AND SECONDARY PRIME PROCESS SUCCESSFULLY, THE REPORTED ALARM WAS NOT REPLICATED. THE UNIT BACK PRIME ON SECONDARY PORT WAS PERFORMED CORRECTLY. NO BLOCKAGE WAS DETECTED AT THE KIT AND SECONDARY PORT DURING EVALUATION PERFORMED. NO LEAKS WERE FOUND DURING THE UNDERWATER LEAK TEST. NO MANUFACTURING DEFECTS WERE FOUND IN THE SAMPLES RECEIVED. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. OTHER SAMPLE EVALUATIONS: VISUALLY CONFIRMED ON THE SURFACE OF THE I-SITE LAV THAT THERE WAS NO SLIT THROUGH THE TOP SURFACE OF THE SILICONE. THEREFORE, THE FLUID WAS BLOCKED FROM MOVING IN EITHER DIRECTION THROUGH THE VALVE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED DURING TRAINING BY A FRESENIUS KABI TRAINER: "PUMPS ARE ALARMING SECONDARY OCCLUSION ALARM WHEN TRYING SYRINGES (MEDLINE 20 ML SYRINGES SYR12001) OR SECONDARY LINES (BBRAUN SECONDARY SET V1921 40 IN). I HAVE SWAPPED OUT 10 PUMPS AND 10 SETS AND I TRIED DIFFERENT SYRINGES AND DIFFERENT SECONDARY SET, ALL HAVE THE SAME OCCLUSION ALARM. I HAVE TRIED TAKING THE SET OFF AND PUTTING IT BACK ON, I HAVE TRIED PULLING THE SYRINGE BARREL OUT AND BACK TO BREAK THE STICTION. WHEN I USED MY SET I BROUGHT FROM HOME WITH A DIFFERENT LOT- MINE WORKED. THE SECONDARY SET AND THE SYRINGE BOTH WORKED ON MY SET THAT I BROUGHT WITH ME." REPORTING DUE TO THE REFERENCED ISSUE. OCCURRED DURING TRAINING; NO ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220672 LVP PRIMARY ADMIN SET 2 INLET ADMINISTRATION SET FPA FRESENIUS KABI USA, LLC 3006073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown