BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1821791 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03023
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    May 2, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE DEVICE HAS BEGUN, HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR AS THE TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. THE CURRENT LABELING FOR THE PATIENT AT-HOME GUIDE - HOMECHOICE/HOMECHOICE PRO APD SYSTEMS AND TRAINER'S GUIDE- HOMECHOICE/HOMECHOICE PRO APD SYSTEMS WAS FOUND TO BE SUFFICIENT FOR THE USE ERROR IDENTIFIED IN THIS REPORT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 3551 ML. THE LARGEST PRESCRIBED FILL VOLUME WAS 2100 ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010 REGARDING THE IIPV FOUND DURING EVALUATION. ACCORDING TO THE NURSE THE PATIENT NEVER REPORTED ANY SYMPTOMS OF OVERFILL. PRODUCT SURVEILLANCE NOTIFIED THE NURSE OF THE PROBABLE CAUSE. THE NURSE ADVISED SHE WILL ADJUST THE TIDAL ULTRAFILTRATION REMOVAL. THE NURSE STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR