BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3812166 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15521
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO OBSERVED AIR IN THEIR PATIENT LINE BETWEEN THE TRANSFER SET AND THEIR EXIT SITE. AT THE TIME OF THE OBSERVED AIR, THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE FOR FILL 3 OF 4 OF PERITONEAL DIALYSIS THERAPY. THERE WERE NO PROBLEMS REPORTED RELATED TO THE TRANSFER SET. PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT ON RE-PRIMING THE PATIENT LINE. THE PATIENT WAS ADVISED TO NOTIFY THEIR NURSE REGARDING THE EVENT. IT WAS UNKNOWN HOW THE PATIENT COMPLETED THERAPY. 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
    291915 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE