BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3249568 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19840
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM 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 RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) WHILE CONNECTED DURING PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NOTHING UNUSUAL NOTED WITH THE SUPPLIES. THE PATIENT WAS PROPERLY PRIMED BEFORE CONNECTING, ALL BAGS WERE PROPERLY CONNECTED AND THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. PD THERAPY WAS DISCONTINUED AND THE PATIENT DISCONNECTED FROM THE SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350027 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE