BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3940680 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-22966
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LINE WAS FULL OF AIR BUBBLES DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE PATIENT WAS CONNECTED TO THE PATIENT LINE AT THE TIME OF THE OBSERVED AIR. A DEFINITIVE CAUSE FOR THE AIR BUBBLES WAS NOT IDENTIFIED DURING TROUBLESHOOTING. PROPER PROCEDURES WERE REVIEWED AND THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CARE GIVER IN ENDING THERAPY. THE CARE GIVER WAS ADVISED TO START THERAPY OVER USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418540 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE