BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4250308 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40448
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 20, 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). THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG IDENTIFIED THE INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. UPON CONCLUSION OF THE INVESTIGATION, 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 WARNS THE USER THAT SETTING THE MINIMUM DRAIN VOLUME % TOO LOW, COULD RESULT IN AN INCOMPLETE DRAIN 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. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 04:26:55. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 1624ML, INDICATING THE HOME PATIENT DRAINED 1624ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737856 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR