BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVP PRIMARY ADMIN 2-SET INLET

    MDR report key: 19279420 · Received May 9, 2024

    Report

    Report Number
    3014732157-2024-00217
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 15, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: 4/22/2024 4:39 PM BY RISK,RDE WHEN ATTEMPTING TO START PT'S CHEMOTHERAPY, THE PRIMARY TUBING ON LOT NUMBER FA23E22360 HAD AN ISSUE WITH THE Y SITE, WHERE THE CHEMO SET WAS ATTACHED. IT SAID IT WAS OCCLUDED. I HAD TO PRIME A NEW PRIMARY TUBING AND ATTACH THE CHEMO TO THAT SET INSTEAD, USING ALL NEW TUBING AND A NEW EQUISHIELD. SECONF OCCURANCE REPORTED BY CUSTOMER. 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 OR PICTURE WAS AVAILABLE FOR ANALYSIS. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331133 LVP PRIMARY ADMIN 2-SET INLET ADMINISTRATION SET, PRODUCT FPA FRESENIUS KABI USA, LLC FA23E22360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown