BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 17277950 · Received July 7, 2023

    Report

    Report Number
    1416980-2023-03400
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 11, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 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 THERE WAS A DISCONNECTION BETWEEN THE SUPPLY LINE OF A HOMECHOICE CASSETTE AND THE SUPPLY BAG WHICH RESULTED IN LEAK. THIS WAS OBSERVED DURING FILL FIVE OF FIVE OF PERITONEAL DIALYSIS THERAPY. THE EVENT WAS FURTHER DESCRIBED AS ¿THE SUPPLY BAG DISCONNECTED FROM THE CASSETTE TUBING AT THE CONNECTION POINT " AND "SOLUTION LEAKED ON THE FLOOR¿. RENAL THERAPY SERVICES REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE PATIENT AND DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. 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
    2030015 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DIANEAL LOW CAL 2.5%| HOMECHOICE PRO DEVICE