BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 2081827 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05626
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. THE RITE (RETURN INSTRUMENT TEST AND EVALUATION) TEST WAS PERFORMED. THE DEVICE FAILED THE HOMECHOICE RITE FUNCTIONAL TEST DUE TO ACCURACY FAILURE. THE HOMECHOICE RITE ELECTRICAL TEST PASSED WITH NO ISSUES ENCOUNTERED. INTERNAL AND EXTERNAL VISUAL INSPECTIONS WERE PERFORMED. NO PROBLEMS WERE ENCOUNTERED. DURING THE EVALUATION, THE DEVICE PASSED ALL TESTING FOR TEMPERATURE AND VOLUMETRIC ACCURACY. THE REPORTED ISSUE OF PATIENT SYMPTOM WAS NOT CONFIRMED DURING THE EVALUATION. ISSUES SUCH AS PATIENT SYMPTOM WOULD NOT BE RECORDED IN THE LOGS OR REPRODUCIBLE. BASED ON THE EVALUATION RESULTS, THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE RITE FUNCTIONAL FAILURE OF ACCURACY FAILURE WAS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REPORTED IN THIS EVENT HAS BEEN RECEIVED BUT THE EVALUATION HAS NOT YET BEGUN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER ON (B)(6) 2011 TO REPORT UREMIC SYMPTOMS WHILE USING THE DEVICE. THE HP'S DOCTOR HAD REQUESTED THAT THE DEVICE BE SWAPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other LOCAL (PD4) ULTRABAG| LOCAL (PD4) AMBUFLEX