BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3041653 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08789
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE IS UNDETERMINED FOR THE REPORTED SYSTEM ERROR 2240 ALARM. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, AND A BATCH REVIEW WAS NOT PERFORMED TO CONFIRM THE PROBLEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP 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 LINE) DURING INITIAL DRAIN ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AND USES A PATIENT EXTENSION LINE BUT ATTACHES IT PRIOR TO PRIME. THE HP CYCLED POWER AND THE HC ALARMED SE 2367. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE USE OF NEW DISPOSABLES AND REFERRED THE HP TO THE REGISTERED NURSE (RN). THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143643 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR HOMECHOICE