BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4152091 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-34985
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2367 (POWER FAILURE ERROR THAT DISCONTINUES THE PRESENT THERAPY AND IS DUE TO A POSSIBLE AIR IN SET/LINE) ALARM OCCURRED ON A HOME CHOICE (HC) DEVICE DURING DWELL TWO OF PERITONEAL DIALYSIS THERAPY. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THEY HAD A POWER OUTAGE AT HOME WHILE IN DWELL TWO. THE HP STATED THE POWER WAS RESTORED TO THE HOME AND THE HC. THE HP STATED THEY COULD NOT GET BACK TO DWELL TWO, SO THEY ENDED THE THERAPY. THE HP STATED THAT WHILE ENDING THE THERAPY THE HC ALARMED WITH THE SE. THE HP THEN CYCLED THE POWER ON THE HC TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES OR TO PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS TO COMPLETE THE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632595 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE