BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 18424813 · Received January 2, 2024

    Report

    Report Number
    1416980-2023-06851
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 3, 2023
    Report Date
    January 2, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1 MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME, AR 72653, UNITED STATES. BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000, DOMINICAN REPUBLIC. 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 THERE WAS A DISCONNECTION BETWEEN THE SUPPLY LINE OF A HOMECHOICE CASSETTE AND A SUPPLY BAG WHICH RESULTED IN A LEAK. THIS OCCURRED DURING SET UP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. RENAL THERAPY SERVICES DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WITH THE HOME PATIENT. 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
    1679616 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE CLARIA.| UNSPECIFIED PD SOLUTION BAG.