BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4143737 · Received October 6, 2014

    Report

    Report Number
    1416980-2014-34571
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED IN MARCH OF 2012. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. THE DEVICE HISTORY REVIEW REVEALED NO NONCONFORMITIES, REWORK, OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT IDENTIFIED DURING THE EVENT HISTORY LOG REVIEW. THE SAMPLE ANALYSIS REVEALED NO NON-CONFORMING PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE DIRECT CAUSE OF THE PROBLEM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED ALARM OCCURRED THROUGH THE NIGHT DURING THERAPY ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE AND DISCUSSED THE USE OF MANUAL SUPPLIES TO COMPLETE THERAPY. 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
    624713 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1