BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3945004 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23362
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. THE PNEUMATIC SYSTEM WAS TESTED AND FOUND TO BE FUNCTIONING PROPERLY. THE TESTING REVEALED NO LEAK AND ALL PRESSURES WERE CORRECT AND STABLE. THE DEVICE PASSED SEAL, PURGE AND WET DISPOSABLE INTEGRITY TEST AND SUCCESSFULLY COMPLETED A SHORT SIMULATED THERAPY. REVIEW OF THE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR FEELING FULL, NO APPETITE, ABDOMINAL PAIN AND SHOULDER PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). TREATMENT WAS NOT REPORTED. THE CAUSE OF FEELING FULL, NO APPETITE ABDOMINAL PAIN AND SHOULDER PAIN WAS NOT REPORTED. THE CAREGIVER REPORTED THAT THE SYMPTOMS MAY BE RELATED TO AN OVERFILL, HOWEVER, THIS WAS NOT CONFIRMED. THERE WERE NO VOLUMES REPORTED TO DETERMINE IF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OCCURRED. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME OF FEELING FULL, NO APPETITE, ABDOMINAL PAIN AND SHOULDER PAIN WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421434 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization