BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3170706 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15407
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM, NOT INCLUDING I-DRAIN. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, DOCUMENT NUMBER 07-19-63-293 JULY 28, 2010. SECTION 15 "TROUBLESHOOTING" ON PAGES 15-50 TO 15-53 GIVES INSTRUCTIONS ON HOW TO BYPASS LDV ALARM. THE WARNING ON PAGE 15-50 STATES "BYPASSING A LOW DRAIN VOLUME ALARM CAN LEAVE FLUID IN THE PERITONEAL CAVITY AND RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. IIPV COULD RESULT IN A FEELING OF ABDOMINAL DISCOMFORT, SERIOUS INJURY, OR DEATH. IF ANY PATIENT, OR PATIENT CAREGIVER, SUSPECTS THE PATIENT HAS IIPV DURING A TREATMENT, PRESS STOP IMMEDIATELY, THEN PRESS S AND INITIATE A MANUAL DRAIN. THE MANUAL DRAIN PROCEDURE IS LOCATED IN 15.5, MANUAL DRAIN PROCEDURE, ON PAGE 15-59. SEE 15.8, INCREASED INTRAPERITONEAL VOLUME (IIPV), ON PAGE 15-65 IF IIPV IS SUSPECTED. ADDITIONAL CARE SHOULD BE TAKEN TO MONITOR FOR IIPV SYMPTOMS FOR THOSE PATIENTS NOT ABLE TO COMMUNICATE ESSENTIAL INFORMATION TO THE CAREGIVER DURING TREATMENT, SUCH AS SMALL CHILDREN OR INFANTS." THE NOTE ON PAGE 15-53 STATES "IF YOU DO NOT ENCOUNTER A DRAIN NOT FINISHED ALARM, OR IF YOU BYPASS WHILE THE LOW DRAIN VOLUME ALARM IS PRESENT, YOUR NEXT FILL VOLUME WILL EQUAL YOUR PRESCRIBED FILL VOLUME." 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) 2013 23:15:44. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 1655ML, INDICATING THE HOME PATIENT (HP) DRAINED 1655ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2400ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271888 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR