BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3926547 · Received July 10, 2014

    Report

    Report Number
    1416980-2014-22027
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION WAS COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE REPORTED EVENT OF AN UNSPECIFIED SYSTEM ERROR ALARM COULD NOT BE VERIFIED THROUGH THE EVALUATION OF THE DEVICE OR THE DEVICE LOGS. THE MACHINE WAS DETERMINED TO HAVE MET SPECIFICATIONS. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WITH NO ABNORMALITIES NOTED. A ONE HOUR SIMULATED THERAPY WAS PERFORMED WITH NO ALARMS OCCURRING. A SERVICE HISTORY RECORD REVIEW WAS PERFORMED AND REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE EVENT HISTORY LOG WAS PERFORMED WHICH IDENTIFIED THE FOLLOWING ALARMS: CHECK PATIENT LINE AND LOW DRAIN VOLUME. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) MACHINE EXPERIENCED AN UNSPECIFIED SYSTEM ERROR (SE) ALARM. THIS OCCURRED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403618 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1