BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2931540 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02066
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 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). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. 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 CONDITION OF IIPV WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST SPECIFICATIONS. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED DIFFICULTY HIGH DRAIN 104 ALARM. THE CAUSE WAS ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MIN DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 104 ALARM AT THE END OF THERAPY ON THE HOMECHOICE MACHINE(HC). THE CAREGIVER(CG) STATED SHE NORMALLY DOES A MANUAL DRAIN AT THE END OF THERAPY, BUT THE NURSE TOLD HER SHE DOES NOT HAVE TO BECAUSE THE HOME PATIENT(HP) HAD A HIGH ULTRAFILTRATION(UF). THE CG HAD A TOTAL UF OF 1535ML. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASKED THE CG IF THE NURSE WAS AWARE. THE CG STATED NO. THE TSR ADVISED THE CG IT IS RECOMMENDED TO SPEAK WITH THE NURSE IF THE HC DISPLAYS HIGH DRAIN/CONTACT PD NURSE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37644 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE