BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2182891 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09905
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 3, 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).SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CONTACTED THE PATIENT REGARDING THE SYSTEM ERROR 2240 ALARM. THE PATIENT STATED THE ALARM WAS RESOLVED. THE PATIENT STATED THAT HE WAS DOING FINE AND CONTINUING THERAPY. NO SAMPLE WAS AVAILABLE. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING INITIAL DRAIN 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 (B)(4).

    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 INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE TSR FURTHER ASSISTED WITH TROUBLESHOOTING. THE HP CONFIRMED NOTHING UNUSUAL WAS NOTED WITH THE SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES AND CONTACT THE NURSE (RN) TO INFORM OF THE INCIDENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 57 YR HOMECHOICE PRO