BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2974756 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04499
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A REPORT OF PARTICULATE MATTER WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SAMPLE WAS EVALUATED. THE CUSTOMER HAD MARKED WHERE IT WAS PERCEIVED PARTICULATE MATTER WAS PRESENT. A VISUAL INSPECTION WAS PERFORMED AND NO ABNORMALITY WAS FOUND. A THREAD-LIKE PARTICLE SEEN BY THE USER MAY HAVE BEEN THE FINE WELD LINE ON THE CASSETTE, WHICH IS ACCEPTABLE. FUNCTIONAL, CLEAR PASSAGE, AND PRESSURE TESTS WERE PERFORMED WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PLASTIC-LIKE PARTICLE WAS OBSERVED WITHIN THE SET. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78106 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S12G10026

    Patients

    Seq Age Sex Outcome Treatment
    1