BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3183224 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16214
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 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
    MX
    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 OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE USE ERROR, INAPPROPRIATE BYPASS OF THE INITIAL DRAIN WITHOUT LOW DRAIN VOLUME ALARM OCCURRING. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: 07-19-61-244 OCTOBER 2, 2009 HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE. SECTION 18 "TROUBLESHOOTING" IN 18.4.1 ON PAGE 18-37 GIVES INSTRUCTIONS ON HOW TO BYPASS INITIAL DRAIN AND STATES "CONTACT YOUR DIALYSIS CENTER TO LEARN WHEN IT IS SAFE TO BYPASS." PAGE 18-37 ALSO HAS THE WARNING: "BYPASSING AN 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 CAN 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 "DOWN ARROW" AND INITIATE A MANUAL DRAIN. THE MANUAL DRAIN PROCEDURE IS LOCATED IN 18.5, MANUAL DRAIN PROCEDURE, ON PAGE 18-53. SEE 18.8, INCREASED INTRAPERITONEAL VOLUME (IIPV), ON PAGE 18-58 IF IIPV IS SUSPECTED. ADDITIONAL CARE SHOULD BE TAKEN TO MONITOR FOR IIPV SYMPTOMS FOR THOSE PATIENTS NOT ABLE TO COMMUNICATE ESSENTIAL INFORMATION TO THEIR CAREGIVER DURING TREATMENT." 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, TWO INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT(S) WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 23:47:16. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1344ML, INDICATING THE HOME PATIENT (HP) DRAINED 1344ML 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
    282464 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1