BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3222605 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18097
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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
    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. 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 (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DWELL 4 OF 4. THE HOME PATIENT (HP) STATED THAT THEY WERE ASLEEP WHEN THEY GOT THE ALARM. ALL OF THE BAGS WERE EMPTY, THERE WERE NO LEAKS AND THE HP DID NOT DISCONNECT. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ADVISED THE HP TO CYCLE THE POWER OFF AND RETURN TO BED. WHEN THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS CONTACTED, THEY EXPLAINED THE ALARM TO THE HP AND HAD THEM CYCLE THE POWER IN ORDER TO COMPLETE THE END THERAPY PROCESS. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324301 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE