BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4140353 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34396
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO NONCONFORMITIES, FAILURES, REWORK, OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. A REVIEW OF THE SERVICE HISTORY WAS ALSO PERFORMED AND REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT HAD A HIGH DRAIN 104 ALARM DURING NIGHT DRAIN FOUR OF PERITONEAL DIALYSIS THERAPY ON A HOMECHOICE DEVICE. A HIGH DRAIN ALARM OCCURS WHEN A PATIENT HAS DRAINED A VOLUME EQUAL TO 200% OR GREATER THAN THE PATIENT¿S FILL VOLUME IN STANDARD MODE. THE PATIENT WAS AT THE END OF THERAPY AND DID NOT EXPERIENCE ANY PREVIOUS ALARMS OR SYMPTOMS PRIOR TO THE EVENT. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH CLEARING THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618072 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR DIANEAL 4.25% AMBUFLEX