BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2944710 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-03012
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. PER THE CUSTOMER THE SAMPLE WAS DISCARDED 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM AND A LEAKING TRANSFER SET, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 3/3. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE CALLER TO END THERAPY AS THE TRANSFER SET WAS LEAKING AND TOLD THE CALLER TO CALL THE REGISTERED NURSE (RN) OR GO TO HOSPITAL AS SOON AS POSSIBLE DUE TO THE LEAK. THE CALLER SAID THE PROBLEM STARTED YESTERDAY. THE HOME PATIENT (HP) SAID THE FILL VOLUME (FV) WAS EQUAL TO 2000ML AND THE DRAIN VOLUME WAS AT 1019ML. THE CALLER WOULD CALL BACK IF ANY PROBLEMS OR QUESTIONS. 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
    48113 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOME CHOICE