BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3230690 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18731
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER ANALYZING THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT INCORRECTLY DISCONNECTING AND RECONNECTING DURING 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 DISCONNECTING AND RECONNECTING THE TRANSFER SET TO THE PATIENT LINE DURING EMERGENCIES. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO DISCONNECTED INCORRECTLY FROM THERAPY AND EXPERIENCED A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING DRAIN. WHEN DISCONNECTING, THE PATIENT CAPPED THE CATHETER AND PUT A FOIL WRAPPER ON THE PATIENT LINE. THE PATIENT LATER RECONNECTED TO CONTINUE THERAPY. THE POWER WAS CYCLED TO CLEAR THE ALARM AND PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT ON DISCONNECTING DURING THERAPY. THE PATIENT WAS ADVISED TO CONTACT THEIR NURSE REGARDING THE EVENT AND PLANNED TO FINISH THERAPY USING MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330058 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE