BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1992736 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02027
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THE ASSIGNABLE CAUSE FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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)).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) FELT DISTENDED. THE REGISTERED NURSE (RN) INDICATED THE HP ONLY DRAINED 34ML AND THE LAST FILL VOLUME WAS 2000ML. THE RN STATED THE MACHINE SWITCHED TO FILL PREMATURELY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE RN COMPLETE A MANUAL DRAIN AND DRAINED 3472ML. THE TSR REVIEWED THE PROGRAMMING AND THE INITIAL DRAIN ALARM (IDA) WAS SET TO 50ML. THE TSR EXPLAINED TO THE RN THAT DUE TO THE LOW IDA SETTING AND POSSIBLE KINK IN THE LINE ALLOWED THE MACHINE TO FILL. THE RN WOULD CORRECT THE PROGRAMMING AND RESTART THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 32 YR