BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2230336 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11506
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 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). THE REPORTED ISSUE OF AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR POTENTIAL USE/USER ERROR RELATED TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN ALARM ON THE HOMECHOICE MACHINE, THE HOME PATIENT (HP) REPORTED TO BAXTER TECHNICAL REPRESENTATIVE (TSR) THAT THERE WAS AIR IN THE PATIENT LINE. THE HP STATED SHE HAD AIR IN HER PATIENT LINE EVERY NIGHT AND HAD SPOKEN WITH HER DOCTOR. THE TSR GAVE RECOMMENDATIONS OF ENDING THERAPY AND STARTING OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 83 YR HOMECHOICE