BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4243525 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39915
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, ELECTRICAL RETURNED INSTRUMENT TESTING EVALUATION (RITE), AND FUNCTIONAL RITE WERE PERFORMED, AND A RELOAD THE SET 153, RELOAD THE SET 156, RELOAD THE SET 157, AND SYSTEM ERROR 1026 OCCURRED. AN EVENT HISTORY LOG REVIEW REVEALED THE FOLLOWING ALARMS: RELOAD THE SET 157, RELOAD THE SET 156, SYSTEM ERROR 1026, DRAIN NOT FINISHED, CHECK PATIENT LINE, LOW DRAIN VOLUME, RELOAD THE SET 153, CHECK HEATER LINE. TO CORRECT THE RELOAD THE SET 153 AND RELOAD THE SET 156 ALARMS, THE VALVE WAS REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED FAILURE OCCURRED DURING USE ON THE HOMECHOICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727676 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1