BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834508 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05330
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, WHICH IS USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THE ASSIGNABLE CAUSE IS USE ERROR. THE LOT NUMBER IS UNKNOWN THEREFORE, A BATCH REVIEW WAS NOT BE CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOME CHOICE (HC) . THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS AND FOUND THAT THE UNUSED SUPPLY LINE CLAMP WAS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THAT UNUSED LINES MUST BE CLAMPED THE HP CYCLED POWER OFF/ON TO CLEAR THE SYSTEM ERROR 2240 FOLLOWED BY A SYSTEM ERROR 2367, ENDING THERAPY. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVED THE CASSETTE. THE HP IS TO NOTIFY THE PERITONEAL DIALYSIS NURSE (PDN) OF MISSED THERAPY ASAP. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE