BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3965080 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24591
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ISSUE WITH A HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT THE HC BEGAN ALARMING. THE ALARM WAS UNKNOWN. THE HOME PATIENT (HP) PLANNED TO COMPLETE THERAPY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD), AND THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCUSSED ITS USE WITH THE REPORTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440885 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR