BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1961538 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00626
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    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 A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE HP WAS CONNECTED DURING PRIMING. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING A CALL WITH A HOME PATIENT (HP) ON AN ISSUE WITH THE HOMECHOICE (HC) MACHINE, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE THERAPY LOG AND FOUND A SYSTEM ERROR 2240 ALARM HAD OCCURRED. THE TSR EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. THE TSR ADVISED TO LET THE NURSE KNOW ABOUT THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. DURING A FOLLOW-UP THE HP STATED THAT NOTHING WAS NOTICED WITH THE SUPPLIES. THE HP COULD NOT REMEMBER THE CHECK PATIENT LINE ALARM. THE PATIENT STATED HE WAS CURRENTLY PERFORMING THERAPY WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE CYCLER