BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4230321 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39073
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A AIR BUBBLES IN THE PATIENT LINE CAUSED BY THE PATIENT CONNECTING THEMSELVES AND INITIATING THERAPY PRIOR TO PROPERLY PRIMING THE PATIENT LINE. 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 ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE AIR BUBBLES IN THE PATIENT LINE DURING INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE PATIENT HAD NOT COMPLETELY PRIMED THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED IN ENDING THE THERAPY. THE PATIENT PLANNED TO RESTART THERAPY USING NEW SUPPLIES. 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
    712732 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR HOMECHOICE