BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 17597040 · Received August 22, 2023

    Report

    Report Number
    1416980-2023-04228
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 22, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AN INTEGRATED APD SET W/CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THE EVENT WAS FURTHER DESCRIBED AS ¿LEAK WAS COMING FROM INSIDE THE CASSETTE DOOR¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY; THE PATIENT WAS CONNECTED. THE PATIENT PROPERLY TIGHTENED THE CONNECTIONS BEFORE STARTING THERAPY AND NO DAMAGE WAS OBSERVED ON THE CASSETTE. 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
    50564 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRANSFER SET| UNSPECIFIED PD SOLUTION