BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1923750 · Received December 14, 2010

    Report

    Report Number
    1423500-2010-06861
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 16, 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). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE LEFT A VOICEMAIL FOR THE PATIENT'S DIALYSIS NURSE EXPLAINING AN INSTANCE OF IIPV WAS FOUND, DATES, VOLUMES, AND CAUSE. DEVICE EVALUATION: THE HOMECHOICE WAS EVALUATED BY THE PRODUCT ANALYSIS LAB. THE HOMECHOICE WAS DETERMINED TO MEET THE SPECIFICATION REQUIREMENTS RELATIVE TO THE IIPV IDENTIFIED VIA LOG REVIEW. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE AN INSUFFICIENT DRAIN (USE ERROR-TIDAL REMOVAL SET TOO LOW). REVIEW OF THE SERVICE HISTORY REVEALS THE HOMECHOICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM BAXTER. REVIEW OF THE LABELING FINDS THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE SUFFICIENT FOR THE USER ERROR IN THIS COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    AN INSTANCE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING A REVIEW OF THE RETURNED HOMECHOICE (HC) PATIENT EVENT LOG. ON (B)(6) 2010 THE ULTRAFILTRATION VOLUME WAS 1623ML DURING CYCLE 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR