BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3102218 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11780
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240/2367 (AIR IN LINE) DURING INITIAL DRAIN ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SYSTEM ERROR 2240 TO THE HOME PATIENT (HP) AND INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS AND CYCLE THE POWER ON THE HC. THE SYSTEM ERROR 2367 FOLLOWED ON THE HC. THE TSR EXPLAINED THE SYSTEM ERROR 2367 TO THE HP AND HAD THE HP TURN THE HC OFF. THE TSR ADVISED THE HP THEY MUST START OVER WITH ALL NEW SUPPLIES DUE TO BOTH SYSTEM ERRORS. THE TSR ALSO ADVISED THE HP TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) AS SOON AS POSSIBLE TO NOTIFY THEM OF THE SYSTEM ERRORS AND THE HP UNDERSTOOD. THE HP STATED THEY DID NOT DO ANYTHING DIFFERENT ON THE HC TONIGHT AND DID NOT NOTICE ANYTHING DIFFERENT AT ALL ABOUT THE SUPPLIES. THE HP WAS TO START OVER WITH NEW DISPOSABLES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203156 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE