BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1932459 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07030
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 24, 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). THREE OF 4 EMDRS. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION OPERATIONAL AND IN GOOD CONDITION. A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. EXTERNAL & INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE CAUSE FOR THE IIPV FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; THE CLINICIAN INAPPROPRIATELY SET THE MINIMUM DRAIN VOLUME PERCENTAGE SETTING TOO LOW. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE DEVICE WAS WITHIN SPECIFICATION RELATIVE TO IIPV FOUND IN THE LOGS. 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 (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2010 DURING POST THERAPY. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2300 ML AND THE DRAIN VOLUME WAS 3709 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP)'S NURSE TO NOTIFY THE IIPV FOUND DURING EVAL, THE NURSE STATED THAT THE HP RECEIVED A TRANSPLANT A FEW MONTHS AGO AND THAT HIS CHARTS WERE CLOSED OUT.

    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 63 YR