BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243810 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12081
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 ALARM. COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECIEVED. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA/NCR (B)(4) AND (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND THAT THE HP NEEDED DISCARD THE SUPPLIES AND START OVER WITH NEW SUPPLIES. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO 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 HOME CHOICE