BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 20788088 · Received November 26, 2024

    Report

    Report Number
    1416980-2024-06843
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1: THE DEVICE WAS MANUFACTURED AT ONE OF THE FOLLOWING FACILITIES: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000 DOMINICAN REPUBLIC. BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME AR 72653 UNITED STATES. 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 A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL ONE OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. 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
    2367664 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA