BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4131837 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-33997
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. NOT PRIMING THE LINE COMPLETELY BEFORE CONNECTING IS A KNOWN CAUSE OF THIS EVENT. 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. IT 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 FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A FAILURE TO FOLLOW THERAPY STEPS ON THE HOMECHOICE (HC) DEVICE, DURING USE. THE FAILURE TO FOLLOW THERAPY STEPS WAS FURTHER DESCRIBED AS THE PATIENT WAS CONNECTED TO THE HC DEVICE WHILE PRIMING WAS IN PROGRESS. THE HP WAS CONNECTED AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE HP HAD BEEN CONNECTED DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612304 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE