BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3232404 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18784
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IT WAS REPORTED THAT THE TABLE WAS WET AFTER THERAPY ON A HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) HAD ALREADY DISCARDED THE SETUP PRIOR TO CALLING IN. THE HP STATED THAT THE HC WAS NOT WET INSIDE OR ON TOP. THE HP FELT FINE AFTER THERAPY. DURING FOLLOW-UP WITH THE REGISTERED NURSE (RN) AND THE HP, IT WAS STATED THAT THE BAG WAS NOT LEAKING AND THE CASSETTE DID NOT HAVE A HOLE. THE RN AND THE HP WERE NOT SURE WHAT CAUSED THE WETNESS. THE HP'S THERAPY HAD BEEN GOING FINE SINCE THIS EVENT. 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
    332861 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| DIANEAL SOLUTION