BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082539 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10653
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE INITIAL DRAIN STAGE. THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THERE WAS NO REPORT OF ISSUES THAT MIGHT HAVE CAUSED THE ALARM. THE LOT NUMBER WAS NOT PROVIDED, SO NO BATCH REVIEW COULD BE PERFORMED. ALTHOUGH THE HOME PATIENT STATED THAT DRAIN LINE CLAMP (Y SAMPLE PORT CLAMP) WAS LEFT OPENED, LEAVING THE SAMPLE PORT CLAMP OPEN IS NOT A KNOWN THE CAUSE OF THIS ALARM. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED RECEIVED THE SE 2240 AFTER CONNECTED TO MACHINE AND WENT INTO INITIAL DRAIN. THE HP STATED THAT DRAIN LINE CLAMP (Y SAMPLE PORT CLAMP) WAS LEFT OPENED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED ONLY LINES WITH CLAMPS BEING USED FOR THERAPY SHOULD BE OPEN. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES AND CONTACT THE REGISTERED NURSE (RN) ABOUT POSSIBLE INTRODUCTION OF AIR IN THE LINES. THE HC WAS OPERATIONAL. THE SAMPLES ARE UNAVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183187 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE