BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2901688 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00502
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED HOWEVER AN EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF AN IIPV EVENT WAS CONFIRMED THROUGH EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED DURING EVALUATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY; THEREFORE THE DEVICE DID MEET PRODUCT SPECIFICATION RELATED TO THE REPORTED ISSUE OF IIPV-ADULT. THE CAUSE FOR THIS IIPV EVENT WAS A COMBINATION OF FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED, AND TIDAL TOTAL UF REMOVAL SET TOO LOW.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH FEELING FULL AND HAVING ABDOMINAL DISCOMFORT DURING DWELL 4 OF 5 ON THE HOMECHOICE MACHINE (HC). THE CAREGIVER (CG) STATED THE FILL VOLUME WAS 2000ML AND IT WAS TIDAL THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO HAVE THE HOME PATIENT (HP) SIT UP AND MANUALLY DRAIN OUT 3567ML. THE TSR ASSISTED THE NURSE TO END THERAPY. THE TSR ADVISED THE NURSE TO DISPOSE OF CURRENT SUPPLIES EXCEPT FOR THE CASSETTE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9413 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE