BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3874502 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19124
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND A VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED. THE TESTING ALSO INCLUDED ELECTRICAL TESTING, CALIBRATION AND SIMULATED THERAPY AND NO MALFUNCTIONS WERE FOUND. THE EVENT HISTORY LOG REVIEW INDICATED SEVERAL ALARMS, BUT AS THE REPORTED ALARM WAS UNKNOWN, THE PROBLEM COULD NOT BE VERIFIED THOUGH THE LOGS. DURING SAMPLE EVALUATION, A SYSTEM ERROR 1031/2367 WAS FOUND; THE REPORTED CONDITION WAS VERIFIED AS A SYSTEM ERROR 1031. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO THE SOFTWARE. THE SOFTWARE WAS CHANGED, ALONG WITH THE BATTERY, MEMBRANE GASKET, PISTON FOAM, PUMP, AND TUBINGS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) PRO MACHINE EXPERIENCED A ¿CASSETTE ALARM¿. THE REPORTER STATED THAT THE ALARM OCCURRED DESPITE CYCLING THE POWER ON THE HC DEVICE AND REPLACING THE DISPOSABLE CASSETTE. PATIENT INVOLVEMENT AND THE STEP OF SETUP OR THERAPY DURING WHICH THIS OCCURRED ARE UNKNOWN, THOUGH 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
    352204 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1