BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2110845 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06934
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 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). BAXTER CONTACTED THE PATIENT REGARDING THE SYSTEM ERROR 2240 ALARM. THE PATIENT STATED THAT HE WAS OK AND WAS ABLE TO CONTINUE THERAPY. THE PATIENT STATED THE ALARM CLEARED AND ALL SAMPLES WERE DISCARDED. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DWELL 5 OF 7 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING DWELL 5 OF 7. THE HP STATED NOTHING UNUSUAL WAS NOTED WITH THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM INDICATED AIR ENTERED THE SET UP AND ASSISTED WITH CYCLING POWER TO CLEAR THE ALARM. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. 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