BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3903205 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20936
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET) ALARM OCCURRED ON THE HOME CHOICE DEVICE DURING DWELL FOUR OF FOUR OF PERITONEAL DIALYSIS THERAPY. THE PATIENT CYCLED THE POWER TO CLEAR THE ALARM AND THEN ATTEMPTED TO RESTART THERAPY USING THE SAME SUPPLIES. THE HOMECHOICE ALARMED AGAIN AND THE PATIENT WAS ADVISED TO COMPLETE THERAPY USING MANUAL SUPPLIES. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT WOULD CAUSE OR CONTRIBUTE TO THE SYSTEM ERROR 2240 ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381151 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE