BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1994216 · Received February 17, 2011

    Report

    Report Number
    1423500-2011-02068
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS RELATED TO POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (10H23H25), WITH NO DEFECTS NOTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 5 INVOLVED IN THIS PERITONITIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL FOR AN UNRELATED ALARM, THE PERITONEAL DIALYSIS (PD) NURSE REPORTED THE PATIENT WAS DIAGNOSED WITH (B)(6) ON (B)(6) 2011. THE PATIENT WAS NOT HOSPITALIZED AND WAS TREATED WITH ANTIBIOTICS. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. AN EFFLUENT SAMPLE WAS TAKEN PRIOR TO THE START OF ANTIBIOTICS. THE PATIENT BEGAN PD THERAPY THREE YEARS AGO. THE PD SOLUTION WAS NOT CONSIDERED SUSPECT AND WAS NOT STOPPED DUE TO THE PERITONITIS. THE PATIENT'S TRANSFER SET WAS REPLACED. THE NURSE STATED THE PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE AND THE PATIENT HAS BEEN RETRAINED. THE PERITONITIS IS ONGOING AND IMPROVED.

    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 69 YR DIANEAL SOLUTION, HOMECHOICE DEVICE