BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3905704 · Received July 1, 2014

    Report

    Report Number
    1416980-2014-21022
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) CASSETTE WAS RETURNED AND AN EVALUATION WAS COMPLETED. VISUAL INSPECTION IDENTIFIED A CUT IN THE CASSETTE SHEETING. FURTHERMORE, UNDERWATER LEAK TESTING IDENTIFIED A LEAK IN THE IDENTIFIED CUT. CLAMP FUNCTIONAL AND CLEAR PASSAGE TESTS WERE PERFORMED WITH NO ISSUES NOTED. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS PERFORMED, AND IT REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE LOT. THE REPORTED LEAK WAS VERIFIED DURING SAMPLE ANALYSIS. THE CAUSE OF THE LEAK WAS A TEAR IN THE CASSETTE SHEETING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A LEAKING CASSETTE WHILE PRIMING THE DEVICE FOR DIALYSIS THERAPY. ACCORDING TO THE REPORT, AFTER THE PATIENT HAD RECEIVED A SYSTEM ERROR 2046 THEY OBSERVED FLUID TRACES NEAR THE MEMBRANE GASKET AND THE CASSETTE. THE PATIENT WAS NOT CONNECTED TO THE DEVICE WHEN THE FLUID WAS OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384056 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13H19073

    Patients

    Seq Age Sex Outcome Treatment
    1