BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3443708 · Received November 1, 2013

    Report

    Report Number
    1416980-2013-30313
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS (PD) THERAPY, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP STATED THERE WAS AIR IN THE SUPPLY LINE AND THAT EVERYTHING WAS CONNECTED. THE PATIENT LINE HAD BEEN PROPERLY PRIMED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. DURING TROUBLESHOOTING, NO ISSUES WERE NOTED WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE THE POWER TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO RESTART WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562900 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HOMECHOICE