BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4003868 · Received August 12, 2014

    Report

    Report Number
    1416980-2014-26225
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY INDICATED THAT MANUFACTURE OF THE DEVICE IS NOT RELATED TO THE REPORTED ISSUE. A SERVICE HISTORY REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) THAT EXPERIENCED AN INTRA-PERITONEAL VOLUME (IIPV) EVENT WHILE PERFORMING TIDAL PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE. A NURSE REPORTED THAT THE PATIENT HAD DRAINED 3200ML THAT DAY WHILE PERFORMING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE LARGEST PRESCRIBED FILL VOLUME IS 1500ML. THE NURSE REPORTED THAT THE PATIENT DRAINED SLOWLY WHEN LAYING DOWN, BUT DRAINED NORMALLY WHEN STANDING. THE PATIENT REPORTED TO NOT HAVE EXPERIENCED ANY SYMPTOMS RELATED TO THE IIPV EVENT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478219 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1