BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1943191 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07453
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF PARTICULATE MATTER (PM) ON THE SUPPLY LINE SPIKE CONNECTOR. SUPPLY LINE SPIKE CONNECTOR WAS VISUALLY INSPECTED AND NOTED PART CONTAINED BLACK SPOTS. THE COMPLAINT WAS CONFIRMED IN THE LAB FOR PM. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. NOT ENOUGH DATA ARE AVAILABLE WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BLACK SPOT WAS FOUND ON THE SUPPLY LINE. THIS EVENT IS REPORTABLE FOR PARTICULATE MATTER. THE SAMPLE AND LOT NUMBER IS AVAILABLE FOR EVALUATION. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10B26058

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE