BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3903594 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20974
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED WITH CUTS IN THE CASSETTE SHEETING NOTED. A LEAK TEST WAS PERFORMED WITH A LEAK FROM THE CASSETTE NOTED. THE DEVICE ALSO FAILED TO MEET PRESSURE TESTING REQUIREMENTS. CLAMP FUNCTION TESTING AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS NOT RUN ON THE HOMECHOICE MACHINE DUE TO THE PHYSICAL FAILURE FOUND. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE AUTOMATED PD SET WITH CASSETTE, THE DEVICE WAS FOUND TO BE CUT ALONG THE EDGE OF THE CASSETTE SHEETING WELD LOCATED ON THE LOWER RIGHT CORNER OF THE CASSETTE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379569 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13L22013

    Patients

    Seq Age Sex Outcome Treatment
    1