BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2103009 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06484
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 8 ASSOCIATED WITH THIS DEVICE.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 AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO USE ERROR; INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. A DEVICE HISTORY REVIEW REVEALED THAT THE C55 HAD FAILED; HOWEVER, THE HC DEVICE WAS REWORKED AND PASSED ALL SUBSEQUENT TESTING PRIOR TO RELEASE. 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 RTB-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING DRAIN CYCLE 6. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2000 ML AND THE DRAIN VOLUME WAS 3648 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER CONTACTED THE NURSE TO NOTIFY OF THIS INCIDENT OF IIPV THAT WAS FOUND DURING THE DEVICE LOG REVIEW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR