BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 19574793 · Received June 20, 2024

    Report

    Report Number
    1416980-2024-03074
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED CLAMP WOULD POP OPEN AND RESULT IN A LEAK. THE PATIENT'S FLOOR WAS GETTING DAMP. THIS OCCURRED DURING AN UNKNOWN PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY WHEN THE PATIENT CLAMP THE DRAIN BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177593 NI CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male CYCLER| DRAIN BAG