BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3221616 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18053
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM, THE REGISTERED NURSE (RN) STATED THAT SOLUTION LEAKED ALL OVER THE DESK AND FLOOR DURING PATIENT USE. THE LOCATION OF THE LEAK WAS UNKNOWN. THERE WAS NO VISIBLE DAMAGE AND THERE HAD BEEN NO CONNECTION ISSUES. THE INSIDE OF THE HOMECHOICE MACHINE WAS DRY. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE RN IN ENDING THERAPY. DURING FOLLOW-UP, IT WAS FOUND THAT THE PATIENT WAS ABLE TO COMPLETE THERAPY AT A LATER TIME. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320841 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE