BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243469 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12075
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 31, 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 A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS NOT DETERMINED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CAREGIVER (CG) TO CYCLE THE POWER TWICE AND THE ALARMS CLEARED. THE TSR ADVISED THE HP TO START WITH NEW SUPPLIES. THE CAREGIVER (CG) CONTACTED PRODUCT SURVEILLANCE (PS) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING THE ALARM AND WAS INSTRUCTED TO DO MANUAL SUPPLIES THAT NIGHT AND THE FOLLOWING AFTERNOON. THE HP RESUMED THERAPY ON THE CYCLER THE FOLLOWING NIGHT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WERE 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 62 YR HOMECHOICE