BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3081553 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10588
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL WAS SET TOO LOW. THE FOLLOWING LABELING WAS REVIEWED: HOMECHOICE APD SYSTEMS TRAINER'S GUIDE. SECTION 12 "PROGRAMMING A PRESCRIPTION" IN 12.4.4 AND 12.4.5 PGS 12-28 TO 12-40 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." THE TOTAL UF IS DEFINED ON PAGE 12-30 AS "TOTAL UF EXPECTED FOR THE NIGHTTIME PORTION OF THE THERAPY. THE SYSTEM CALCULATES THE UF PER CYCLE. THE UF PER CYCLE PLUS THE TIDAL VOLUME IS THE AMOUNT OF SOLUTION DRAINED DURING EACH TIDAL DRAIN." 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. " PG 12-31 ALSO HAS THE NOTE THAT "IF YOU USE A SOLUTION FOR A TIDAL THERAPY THAT IS DIFFERENT FROM THE SOLUTION USED IN THE PREVIOUS THERAPY, YOU MAY NEED TO ADJUST THE TOTAL UF BASED ON THE CONCENTRATION OF THE NEW SOLUTION." FOR HD TIDAL THERAPY SETTINGS, A WARNING ON PG 12-37 STATES "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" AND THE SUGGESTED SETTING IS DESCRIBED ON PG 12-37 AS "SEVENTY PERCENT OF THE NORMAL NIGHTTIME UF IS A GOOD STARTING POINT FOR DETERMINING THE OPTIMUM NIGHT UF." IN ADDITION, 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." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2013 AT 00:21:08. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1326ML, INDICATING THE HOME PATIENT (HP) DRAINED 1166ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1600ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184008 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1