BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1884478 · Received October 28, 2010

    Report

    Report Number
    1423500-2010-05007
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS EVENT INVOLVES THREE BAXTER PRODUCTS. THIS IS REPORT 3 OF 3.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (10D12H25, 10C02H25) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT IS UNDETERMINED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH ENDING THERAPY WHILE USING THE HOMECHOICE (HC) CYCLER. THE PATIENT STATED THEY HAD AN INFECTION AND NEEDED TO GO TO THE HOSPITAL. THE PATIENT HAD FIBRIN AND CLOUDY FLUID. GTS ASSISTED THE PATIENT IN ENDING THERAPY. DURING FOLLOW UP CONVERSATION WITH THE PATIENT'S NURSE, IT WAS REVEALED THAT THE PATIENT HAD PERITONITIS. THE ORGANISM IDENTIFIED WAS (B)(6). THE PATIENT WAS TREATED WITH VANCOMYCIN. THE NURSE INDICATED THAT THE PERITONITIS WAS NOT DIALYSIS RELATED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R