BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4250361 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40421
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO CONNECTED THEMSELVES TO THEIR PATIENT LINE PRIOR TO THE LINE BEING PROPERLY PRIMED. 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

    IT WAS REPORTED THAT A PATIENT HAD CONNECTED THEMSELVES TO THE PATIENT LINE OF THEIR CASSETTE AND INITIATED PERITONEAL DIALYSIS THERAPY PRIOR TO LINE BEING PROPERLY PRIMED. PROPER PROCEDURES WERE REVIEWED AND THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH ENDING THERAPY. THE PATIENT WAS ADVISED TO NOTIFY THEIR NURSE OF ANY MISSED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737691 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE