BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3811994 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15565
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. A VISUAL INSPECTION WAS PERFORMED WITH NO ABNORMALITIES NOTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A REVIEW OF THE EVENT HISTORY LOGS WAS UNABLE TO IDENTIFY THE REPORTED ALARM. FUNCTIONAL TESTING REVEALED THAT THE MACHINE ALARMED WITH NO MESSAGE ON THE SCREEN. THIS WAS DETERMINED TO CONFIRM THE REPORTED CONDITION. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO A MALFUNCTIONING DIGITAL BOARD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DIGITAL PRINTED CIRCUIT BOARD (PCB) WAS SCRAPPED TO SOLVE THE PROBLEM. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED ALARM ON THE HOMECHOICE DEVICE. IT WAS NOT SPECIFIED WHEN IN THE THERAPY THIS OCCURRED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291843 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1