BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2183416 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09954
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    December 1, 2009
    Report Date
    July 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (11C23H25) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) FROM A NURSE OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A MALE PATIENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON AN UNREPORTED DATE IN (B)(6) 2010. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED ON AN UNREPORTED DATE IN (B)(6) 2010. THE PATIENT WAS RECOVERED ON AN UNREPORTED DATE. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THE PERITONITIS WAS CAUSED BY BATH WATER THE PATIENT SOAKED IN AND WAS NOT RELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R DIANEAL THERAPY| DIANEAL PD4 AMBUFLEX