BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2012340 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02948
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. A REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME THAT MEET THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE PAL EVALUATED THE DEVICE. WITH REFERENCE TO THE IIPV DECISION TREE, THE PROBABLE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN, TIDAL UF REMOVAL SET TOO LOW. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPVS. THE DEVICE MET SPECIFICATIONS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE DEVICE, AN ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE THERAPY LOGS: OCCURRENCE DATE (B)(6) 2010, CYCLE 5, DRAIN VOLUME OF 4157 MILLILITERS (ML). ON 25 FEB 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) WHO STATED HE DOES NOT RECALL ANY LARGE DRAIN VOLUMES. THE HP STATED HE HAS HAD NO SYMPTOMS OF OVERFILL AND FURTHER CONFIRMED HE WAS DOING FINE WITH THERAPY.

    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 64 YR