BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3211218 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17728
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. A REVIEW OF THE EVENT HISTORY LOG OF THE DEVICE FOUND NOTHING RELATED TO THE REPORTED ISSUE. DURING DEVICE EVALUATION, THE REPORTED ISSUE COULD NOT BE CONFIRMED OR REPLICATED. AS A RESULT, THE ROOT CAUSE OF THE REPORTED ISSUE CAN NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL OCCURRENCE DATE AND THE THERAPY DATE IS UNKNOWN AT THIS TIME. THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) FELT "OVERFULL" WHEN THEY WOKE UP WHILE PERFORMING THE THERAPY ON THE HOMECHOICE (HC) DEVICE. THE HP WAS ABLE TO CONTINUE THE THERAPY ON ANOTHER HC. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. REPORT 2 OF 2 FOR THIS PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309839 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 PD DISPOSABLES/1.5% AND 2.5% DIANEAL