BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2213170 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10767
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 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). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CHECK THE PATIENT LINE. THE HP STATED THAT THERE WAS AIR IN IT. THE TSR ADVISED THE HP TO DISCONNECT AND CYCLE POWER. A SE 2367 ALARMED. THE TSR ADVISED THE HP TO CALL THE REGISTERED NURSE (RN) IN THE MORNING FOR THERAPY ASSISTANCE. THERE WAS PATIENT INVOLVEMENT.

    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 74 YR HOMECHOICE