BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3971244 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24846
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A SYSTEM ERROR 2240 ALARM THAT WAS CAUSED BY THE PATIENT CONNECTING THEMSELVES TO THE PATIENT LINE DURING THE PRIMING PHASING OF PERITONEAL DIALYSIS THERAPY. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. THE GUIDE WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE DEVICE, IT WAS REPORTED THAT THE HOME PATIENT WAS CONNECTED TO THE PATIENT LINE OF THE CASSETTE DURING THE PRIMING PHASE OF PERITONEAL DIALYSIS THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT END THERAPY AND CYCLE THE POWER ON THE HOMECHOICE. PROPER PROCEDURES WERE REVIEWED AND THE TSR AIDED THE PATIENT IN RESTARTING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446931 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE