BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3151309 · Received June 7, 2013

    Report

    Report Number
    1416980-2013-14573
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    July 15, 2012
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: (B)(4) HOMECHOICE APD SYSTEMS TRAINER'S GUIDE. SECTION 12 "PROGRAMMING A PRESCRIPTION" IN 12.4.4 AND 12.4.5 PAGES 12-28 TO 12-40 GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS IN STANDARD MODE AND HIGH DOSE TIDAL SETTINGS IN STANDARD MODE. PAGE 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 INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. IIPV COULD RESULT IN A FEELING OF ABDOMINAL DISCOMFORT, SERIOUS INJURY, OR DEATH. SEE TOPIC 10: INCREASED INTRAPERITONEAL VOLUME (IIPV) ON PAGE 13-37 FOR IIPV SYMPTOMS OR IF IIPV IS SUSPECTED." THE TOTAL UF IS DEFINED ON PAGE 12-30 AS "TOTAL ULTRAFILTRATION (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 PAGE 12-30 AS "SEVENTY PERCENT (70%) OF THE NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING THE OPTIMUM TOTAL UF. FOR HELP IN CONVERTING 70% OF THE EXPECTED TOTAL THERAPY ULTRAFILTRATION INTO A VALUE THAT CAN BE PROGRAMMED AS THE TOTAL UF FOR A TIDAL THERAPY, SEE HOW DO I DETERMINE TIDAL TOTAL UF AND LAST MANUAL DRAIN UF TARGET VOLUME SETTINGS? ON PAGE 13-12." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING 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 21:53:14. DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 1285ML, INDICATING THE HOME PATIENT (HP) DRAINED 1195ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252778 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1