BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2132633 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07754
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS COINCIDENT WITH PHYSIONEAL, UNSPECIFIED PRODUCT THERAPY. IN 2002, THE PATIENT BEGAN TREATMENT WITH PHYSIONEAL, UNSPECIFIED PRODUCT, (DOSE, FREQUENCY NOT REPORTED), THE PATIENT BEGAN TREATMENT WITH PHYSIONEAL, UNSPECIFIED PRODUCT, (DOSE, FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. THE PATIENT PRESENTED WITH A CLOUDY BAG AND FURTHER EXPLAINED THE "COLOUR BURG (RING PULL) COMES OFF WHEN SHE OPENS THE BAGS." THE PATIENT USED 2 OF THE BAGS BUT HAS SINCE BEEN ADVISED NOT TO USE ANYMORE. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED AND THE SEVERITY WAS CONSIDERED MILD. FROM (B)(6) 2011, THE PATIENT WAS TREATED WITH "VANC" 2GM X2 IP. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH "VANC" X1 IP. ON (B)(6) 2011, A SUBSEQUENT PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED WITH RESULTS NOT REPORTED. ON THE SAME DAY, THE PATIENT RECOVERED FROM THE EVENT OF CLOUDY EFFLUENT. THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE ROOT CAUSE OF THE CLOUDY EFFLUENT WAS "MOST LIKELY DUE TO COLOURED BURG." PHYSIONEAL REMAINED ONGOING. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS "MOST LIKELY DUE TO COLOURED BUNG" (PREVIOUSLY REPORTED AS BURG). THE NURSE BELIEVED THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS AUREUS WAS UNRELATED TO PHYSIONEAL, UNSPECIFIED PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention PHYSIONEAL