BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183477 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09963
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 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) ALARM DURING DWELL 2 OF 2 WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. 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 REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET), DURING DWELL 2 OF 2 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) HAD NOT DISCONNECTED, NO LEAKS AND ALL THE UNUSED LINES WERE CLOSED. THE HP CYCLED THE POWER AND THE TSR ASSISTED TO RETRIEVE THE CASSETTE AND ADVISED TO CONTACT THE REGISTERED NURSE (RN). PRODUCT SURVEILLANCE CONTACTED THE PD RN ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE PD RN STATED THE HP DID NOT CONTACT HER ABOUT THE ALARM. THE PD RN STATED THE HP DISCARDS HIS SUPPLIES AND THAT HE WAS DOING FINE WITH THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 45 YR HOMECHOICE