BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2193275 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10323
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) MACHINE DURING DWELL 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE THE POWER, AND CLOSE THE CLAMPS. THE HP STATED THE HC WENT TO PRESS GO TO START. THE TSR HAD THE HP DISCONNECT AND ASSISTED THE HP WITH GETTING THE SET OUT. THE TSR EXPLAINED THE ALARMS TO THE HP, AND EXPLAINED THE HP TO FINISH THE THERAPY WITH MANUAL BAGS. THE TSR RECOMMENDED THE HP CONTACT THE NURSE ABOUT THE ALARM. NO FURTHER INFORMATION IS AVAILABLE. 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 HOMECHOICE