BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3062746 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09495
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW. THE FOLLOWING LABELING WAS REVIEWED: 07-19-63-294 AUGUST 6, 2010 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. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    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 IN THE THERAPY INITIATED ON (B)(6) 2012 AT 21:16:36. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 1208ML, INDICATING THE HOME PATIENT (HP) DRAINED 908ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164386 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1