BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3940082 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-22939
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A SYSTEM ERROR 2240 ALARM THAT WAS CAUSED BY THE PATIENT CONNECTING THE EXTENSION SET TO THE PATIENT LINE AFTER THE PRIMING PHASE 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. IT INSTRUCTS THE USER TO CONNECT THE PATIENT LINE EXTENSION SET TO THE PATIENT LINE PRIOR TO PRIMING. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. A 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 SYSTEM ERROR 2240 ALARM (AIR IN LINE/SET) OCCURRED ON THE HOMECHOICE DEVICE DURING A DRAIN PHASE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD CONNECTED THE EXTENSION LINE TO THE PATIENT LINE AFTER PRIMING. THE POWER WAS CYCLED TO CLEAR THE ALARM AND PROPER PROCEDURES WERE REVIEWED. THE PATIENT WAS TO START THERAPY OVER USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417895 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE