BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3926475 · Received July 10, 2014

    Report

    Report Number
    1416980-2014-22019
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    February 25, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG IDENTIFIED THE IIPV EVENT. THE CAUSE OF THE IIPV EVENT WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR, FURTHER SPECIFIED AS THE MINIMUM DRAIN VOLUME PERCENT WAS SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE PROVIDES A WARNING "IF YOU SET THE MINIMUM DRAIN VOLUME % TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 AT 20:03:37. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1450ML, INDICATING THE HOME PATIENT (HP) DRAINED 1450ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404752 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1