BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2920105 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01257
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    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, BASED ON THE CUSTOMER REPORT. THE ASSIGNABLE CAUSE IS DETERMINED TO BE USER ERROR BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, WHICH IS A USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 4 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS AND FOUND THAT THE CLAMP ON THE UNUSED LINE WAS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS AND CYCLE THE POWER OFF/ON TO CLEAR THE SE 2240 FOLLOWED BY THE SE 2367 ENDING THERAPY. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVED THE CASSETTE. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE (PDN) OF THE MISSED THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25995 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOMECHOICE