BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2991396 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05411
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SE 2240 WAS NOT COFIRMED AS THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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) 2240/2367 (AIR IN SET) DURING DWELL 3 OF 4 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THERE WERE NO LEAKS, THE HOME PATIENT (HP) DID NOT DISCONNECT AND THERE WERE NO UNUSED LINES OPEN. THE HP CYCLED THE POWER AND THE CYCLER WENT TO THE END OF THERAPY. THE HC DID NOT POWER OFF AND THE TSR ASSISTED THE HP TO RETRIEVE THE CASSETTE AND ADVISED HIM TO LET THE REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94972 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE