BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3073313 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10121
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 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 A FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAIN. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, SECTION 15 "TROUBLESHOOTING" ON PAGES 15-43 TO 15-45 GIVES INSTRUCTIONS ON HOW TO BYPASS LDV ALARM IN INITIAL DRAIN. THE WARNING ON PAGE 15-43 STATES: "BYPASSING A LOW DRAIN VOLUME ALARM DURING INITIAL DRAIN WHEN THERE IS STILL FLUID LEFT IN THE PERITONEAL CAVITY CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION LATER IN YOUR THERAPY. CHANGE YOUR POSITION OR SIT UP TO AID DRAINING COMPLETELY DURING THE INITIAL DRAIN. 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 LABELING ALSO STATES ON PAGE 15-44 THAT "BY SELECTING BYPASS, YOU INDICATE THAT YOU ARE EMPTY. THE SYSTEM CONSIDERS YOUR VOLUME ZERO (0) AND DELIVERS YOUR ENTIRE PRESCRIBED FILL VOLUME." 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 01:01:04. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1521ML, INDICATING THE HOME PATIENT (HP) DRAINED 1521ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174604 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR