BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2181727 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09853
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW WAS DETERMINED TO BE INSUFFICIENT DRAIN, USE ERROR, TIDAL ULTRAFILTRATION (UF) REMOVAL SET TOO LOW. DEVICE MET SPECIFICATIONS RELATIVE TO IIPV IN THE LOGS. A LABEL REVIEW WAS PERFORMED AND FOUND TO BE SUFFICIENT. ADDITIONAL INFORMATION WAS OBTAINED BY BAXTER FROM THE NURSE. PER THE PATIENT'S NURSE, THE EXCESSIVE DRAIN VOLUME WAS RELATED TO POST-SURGICAL INTRA-ABDOMINAL BLEEDING AND NOT DEVICE OVERFILL. THE PATIENT NOW HAS FULL KIDNEY FUNCTION AND IS NO LONGER RECEIVING DIALYSIS. ALL CLINICAL AND DEVICE DATA HAS BEEN REVIEWED IN DETAIL. THERE IS NO SERIOUS INJURY OR INTERVENTION TO PREVENT SUCH REPORTED IN THIS EVENT THAT IS CAUSALLY RELATED TO A BAXTER DEVICE. THIS DOES NOT REPRESENT A DEVICE FAILURE MODE, MALFUNCTION AND/OR USE ERROR THAT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WERE IT TO RECUR.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOMECHOICE (HC) MACHINE, AN ADDITIONAL ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE PATIENT EVENT LOGS: OCCURRENCE DATE (B)(6) 2011 AT 13:47 WITH DRAIN VOLUME OF 749 MILLILITERS (ML) DURING INITIAL DRAIN. THE LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 400 ML. THIS MEETS THE CRITERIA FOR IIPV. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1