BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3003933 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06102
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    December 25, 2012
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    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 IIPV WAS CONFIRMED BY REVIEW OF THE 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. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, (B)(4). HOMECHOICE APD SYSTEMS TRAINER'S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. PG 12-30 HAS THE WARNING THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN IIPV SITUATION. " SECTION 13 "TOPIC 4: TIDAL THERAPY" GIVES THE TRAINER INSTRUCTIONS ON HOW TO PROPERLY SET TIDAL THERAPY VALUES. ON PG 13-9 THE INSTRUCTIONS STATE "A GOOD STARTING POINT WOULD BE, AT A MINIMUM, TO REVIEW A DRAIN HISTORY OVER THE PREVIOUS SEVEN TREATMENT DAYS. THE TOTAL AMOUNT OF UF OVER THE SEVEN DAYS SHOULD BE ADDED AND THEN DIVIDED BY SEVEN TO OBTAIN AN AVERAGE DAILY UF GOAL." THE SUGGESTED SETTING FOR TOTAL UF IS DESCRIBED ON PG 12-30 AS "SEVENTY PERCENT OF THE NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING THE OPTIMUM TOTAL UF. "

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING DRAIN CYCLE 5. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 1537 ML, INDICATING THE HOME PATIENT (HP) DRAINED 1537ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2000ML. THIS MEANS THE TOTAL DRAIN VOLUME WAS APPROXIMATELY 3537ML, WHICH MEETS THE IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107493 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE