BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1953286 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00298
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 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). ONE UNUSED / UNOPENED SET WAS RECEIVED IN ORIGINAL PACKAGING IN REFERENCE TO THE PARTICULATE MATTER (PM). A VISUAL INSPECTION OF THE CASSETTE REVEALED LOOSE PARTICULATE OUTSIDE OF THE FLUID PATH. THIS IS CONSIDERED A COSMETIC MINOR DEFECT THAT WOULD NOT AFFECT THE INTEGRITY OF THE SET. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE DEPARTMENT CLEANING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT A BLACK SPOT WAS FOUND ON THE PATIENT LINE. THIS COULD POTENTIALLY BE PARTICULATE MATTER. NO INJURY IS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 H10F15094

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER