BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3891907 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20094
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG WAS PERFORMED. AS NO SPECIFIC ALARM WAS REPORTED THE ALARM COULD NOT BE IDENTIFIED BUT THE FOLLOWING ALARMS WERE NOTED: LOW DRAIN VOLUME (LDV) ALARM, CHECK LINES AND BAGS (CLB) ALARM, AND A SYSTEM ERROR (SE) 0008. A VISUAL INSPECTION WAS PERFORMED. FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND A SIMULATED THERAPY WERE PERFORMED WITH NO ISSUES NOTED. A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A DEVICE HISTORY REVIEW REVEALED THERE ARE NO NONCONFORMITIES, REWORK ACTIVITIES, OR FIRST PASS TEST SPECIFICATION FAILURES RELATED TO THIS COMPLAINT. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED PROBLEM OCCURRED WITH THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368737 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1