BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3841905 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17524
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN LINE) ALARM OCCURRED ON A HOME CHOICE (HC) DEVICE DURING THE INITIAL DRAIN. THE PATIENT WAS CONNECTED TO THE HC AT THE TIME OF THE ALARM. THE PATIENT INDICATED THAT THE THERAPY WAS STARTED LATE. WHEN HC DISPLAYED ALARM IT WAS TURNED OFF AND ON BUT THE HC WAS STILL ALARMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT REVIEW THE ALARM LOG WHICH SHOWED THE SE 2240. THE TSR EXPLAINED THE ALARM TO THE PATIENT. THE PATIENT WAS ADVISED TO USE NEW SUPPLIES TO COMPLETE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318773 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE