BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 16397570 · Received February 17, 2023

    Report

    Report Number
    1416980-2023-00540
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT/CONCOMITANT MEDICAL PRODUCTS DATE: THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2023. 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 DISCARDED 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 CASSETTE WAS LEAKING BETWEEN THE CONNECTION OF THE SUPPLY LINE AND SUPPLY BAG. THE LEAK WAS FURTHER DESCRIBED AS, ¿LEAKS APPEARED TO BE FROM WHERE THE FRANGIBLE TUBE CONNECTS TO THE CASSETTE." THIS ISSUE OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY. 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
    173925 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE DEVICE| UNSPECIFIED PD SOLUTION