BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2941959 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02804
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER?S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) CYCLER WAS RETURNED FOR DEVICE EVALUATION FOR THE REPORTED CONDITION OF IIPV. THE REPORTED ISSUE WAS CONFIRMED DURING THE EVENT HISTORY LOG REVIEW TASK. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED DIFFICULTY OF HIGH DRAIN 103 ALARM. THE CAUSE WAS ONE OR MORE CYCLES ADVANCED TO NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HI DRAIN 103 ALARM DURING THERAPY ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE CAREGIVER(CG) TO PRESS STOP AND GO TO GET TO START IN ORDER TO REMOVE SUPPLIES. WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47038 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE