BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3041629 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08784
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO NOT REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS 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 CHECK SUPPLY LINE , WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE REGISTERED NURSE (RN) HOW MANY BAGS THE HOME PATIENT (HP) USED. THE RN STATED TWO BAGS. THE TSR ASKED WHAT COLOR CLAMPS WERE ON THE LINES GOING TO THE BAGS. THE RN STATED RED AND BLUE. THE TSR EXPLAINED THE HC PULLS FROM THE HEATER LINE, THEN THE SUPPLY LINE, AND THEN THE FINAL LINE IF THERE WAS NO BAG ON THE SUPPLY LINE. THE RN STATED THEY HAD CHANGED THE SETUP. THE RN STATED THEY MOVED THE BAG TO THE SUPPLY LINE. THE HC ALARMED CHECK FINAL LINE. THE TSR REVIEWED THERAPY SETTINGS. THE TSR ASSISTED WITH TROUBLESHOOTING. 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
    143858 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE