BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3930162 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22405
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE HOMECHOICE (HC) DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN ALARM OCCURRED ON A HOMECHOICE (HC) DEVICE DURING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. 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
    406701 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1