BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1885066 · Received October 28, 2010

    Report

    Report Number
    1423500-2010-05020
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A LEAK FOUND DURING DWELL. THIS COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REQUESTING ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC) UNIT DURING DWELL 1. THE HP STATED THE DRAIN LINE WAS LEAKING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AS REQUESTED. THE HP CONFIRMED SHE WOULD START OVER WITH NEW DISPOSABLES. ON (B)(6) 2010 (B)(4) SPOKE WITH THE HP'S NURSE WHO STATED THAT THE HP WAS SEEN IN THE CLINIC (B)(6) (DATE UNKNOWN) AND THAT THERAPY STEPS WERE REVIEWED WITH THE HP. THE NURSE CONFIRMED THE HP WAS DOING FINE AND CONTINUING THERAPY ON THE HC CYCLER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR