BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3133054 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13447
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 11, 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). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE WET SET WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS FUNCTIONALLY TESTED ON A HOMECHOICE DEVICE WITH NO ISSUES NOTED. THEREFORE THE CAUSE OF THE SYSTEM ERROR 2240 ALARM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING PERITONEAL DIALYSIS, A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON A HOMECHOICE (HC) MACHINE DURING DWELL FOUR OF SIX. THE CAREGIVER (CG) STATED THERE WERE NO OBVIOUS CAUSES OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG IN CLEARING THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237242 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE