BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4183141 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36429
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND AN EVALUATION WAS COMPLETED. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING REVIEW OF THE EVENT HISTORY LOG. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. A VISUAL INSPECTION WAS ALSO PERFORMED. A REVIEW OF THE SERVICE HISTORY FOUND THAT THE PREVIOUS SERVICING OF THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENT SETTING 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 RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014, AT 19:51 DURING NIGHT DRAIN CYCLE THREE. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 925ML, INDICATING THE HOME PATIENT (HP) DRAINED 925ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 1500 ML. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660122 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR