BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3112507 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12326
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET. AND INSTRUCTS THE USER TO CONNECT THE TRANSFER SET TO THE PATIENT LINE PRIOR TO STARTING THE INITIAL DRAIN. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THE HOME PATIENT (HP) DID NOT CONNECT AND PRESSED GO. THEY CYCLED POWER AND WERE AT END OF THERAPY. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213046 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HOME CHOICE