BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3250464 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19897
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, 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 HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR 2240 (AIR IN SET) ALARM. THIS OCCURRED ON A HOMECHOICE (HC) MACHINE DURING DWELL THREE OF FIVE. THE HP COULD NOT ANSWER QUESTIONS ABOUT THE BAG CONNECTION AND WAS NOT SURE WHAT THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS ASKING. THE TSR ASSISTED THE HP IN CLEARING THE ALARM AND IN ENDING THERAPY. NO ADVERSE EVENT WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349558 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PD SOLUTION| HOMECHOICE