BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3083272 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10703
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H12H30030 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE RETURNED SAMPLE A CUT IN THE SHEETING WAS OBSERVED. A LEAK AT THE SITE OF THE CUT IN THE SHEETING WAS FOUND DURING LEAK TESTING. CLEAR PASSAGE AND CLAMP FUNCTION TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A HOME CHOICE CASSETTE, A CUT IN THE CASSETTE SHEETING WAS NOTICED. LEAK TESTING WAS PERFORMED, AND A LEAK WAS NOTED AT THE CUT IN THE SHEETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185896 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12H30030

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOME CHOICE