BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3812087 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15480
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE AFFECTED SAMPLE WAS NOT RETURNED FOR EVALUATION, THOUGH 26 COMPANION SAMPLES WERE. VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE, NOTING NO ABNORMALITIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE COMPANION SAMPLES WERE FUNCTIONALLY TESTED (SIMULATED USE) ON A HOMECHOICE DEVICE, NOTING NO ABNORMALITIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE RETURNED DEVICES PERFORMED WITHIN THE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNSPECIFIED CONNECTION ISSUE, RELATED TO THE INNER DIAMTER OF ONE OF THE CASSETTE LINES. THIS OBSERVATION WAS MADE PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290200 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S13K16025

    Patients

    Seq Age Sex Outcome Treatment
    1