BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3031444 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08141
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER BAXTER LABELING, USERS ARE INSTRUCTED THAT DISPOSABLE PRODUCTS ARE INTENDED FOR SINGLE USE ONLY WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A POWER FAILURE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOUSE HAD LOST POWER FOR FOUR HOURS. THE CALLER HAD STARTED THERAPY OVER WITH THE SAME SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD THE CALLER THAT SUPPLIES COULD NOT BE REUSED ONCE THERAPY ENDS. THE TSR TOLD THE CALLER TO END THERAPY AND START OVER WITH NEW SUPPLIES OR PERFORM MANUAL THERAPY. THE TSR TOLD THE CALLER TO CALL THE REGISTERED NURSE (RN) ABOUT MISSED THERAPY AND REUSING THE SAME SUPPLIES. 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
    134267 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE