BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3973251 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25047
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT DURING THE SERVICE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN 103 ALARM OCCURRED AFTER THERAPY ON THE HOME CHOICE (HC). THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE HOME PATIENT (HP) STATED THE THERAPY WAS TIDAL, THE FILL VOLUME (FV) EQUALED 1500ML, THE TIDAL VOLUME EQUALED 90%, THE TARGET ULTRA FILTRATION (UF) EQUALED 1000ML, AND THERE WAS A FULL DRAIN EVER 4 CYCLES. THE HP STATED THE LAST UF EQUALED 2269ML, THE CYCLE ONE UF EQUALED 182ML, THE CYCLE TWO UF EQUALED 334ML, AND THE CYCLE THREE UF EQUALED 1753ML. 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
    450350 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR