BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1971074 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01044
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT: ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) WHO STATED THAT THERAPY HAS BEEN GOING WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. EVALUATION: THE PRODUCT ANALYSIS LABORATORY (PAL) EVALUATED THE HC. A REVIEW OF THE DEVICE LOGS REVEALED ONE INSTANCES OF IIPV (INCREASED INTRA-PERITONEAL VOLUME). THE PROBABLE CAUSE FOR THE IIPV FOUND IN THE DEVICE LOG WAS NOT DETERMINED. A SERVICE HISTORY REVIEW REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUES RELATED TO IIPV. THE DEVICE WAS IN SPECIFICATION RELATIVE TO IIPV FOUND IN THE LOG. 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

    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 WAS 1892 ML DURING CYCLE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR