BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240584 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11920
    Event Type
    Malfunction
    Date Received
    September 9, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR CHECK PATIENT LINE ALARM IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH NCR (B)(4). THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DRAIN 1. PER THE INITIAL REPORT, THE HOME PATIENT (HP) HAD A CHECK PATIENT LINE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP TROUBLESHOOT. THE HP STATED THERE WAS AIR IN THE PATIENT LINE. THE TSR ADVISED TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 38 YR HOMECHOICE