BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRONG

    MDR report key: 1953854 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00334
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE POUCH WITH INCOMPLETE SEAL BEFORE USE WAS CONFIRMED IN THE LAB. POUCH WAS VISUALLY INSPECTED WITH TOP SEAL OPENED APPROXIMATELY 2 IN CENTER OF SEAL AND A SMALL PUNCTURE ON THE FRONT SIDE OF THE POUCH. THE ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS, AND WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) AN INCOMPLETE SEAL ON THE POUCH OF THE CASSETTE, PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H09J01116

    Patients

    Seq Age Sex Outcome Treatment
    1