BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3243182 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19473
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. SHOULD ADDITIONAL 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) AND SE 2367 (FAIL SAFE SHUT DOWN) ALARM OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND ASSISTED THE CAREGIVER (CG) TO CYCLE THE POWER TO CLEAR THE ALARMS. THE TSR THEN EXPLAINED THAT THE CG WOULD NEED TO START THE THERAPY OVER WITH NEW SUPPLIES AND ADVISED THE CG TO LET THE PATIENT?S REGISTERED NURSE (RN) KNOW ABOUT THE ALARM WITHIN THE NEXT 24 HOURS. THE CG UNDERSTOOD THE EXPLANATIONS, THE ALARMS WERE CLEARED, THEY WOULD START OVER WITH NEW SUPPLIES AND CONTACT THE PATIENT'S RN. 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
    343773 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE