BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE

    MDR report key: 1982382 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01689
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD POTENTIALLY ASSOCIATED LOT NUMBER (H10J20030) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR-POOR ASEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4 FOR THIS INCIDENT OF PERITONITIS. AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A FOLLOW CALL FOR AN UNRELATED ALARM THE PERITONEAL DIALYSIS REGISTERED NURSE(PDRN) CONTACTED PRODUCT SURVEILLANCE ON (B)(6) 2010. THE PDRN REPORTED THAT THE HOME PATIENT(HP) IS BEING TREATED FOR FIBRIN AND PERITONITIS. ON (B)(6) 2010. BAXTER CONTACTED PDRN TO OBTAIN FURTHER INFORMATION ON THIS EVENT OF PERITONITIS. THE NURSE STATED THAT THE PATIENT HAS HAD ONGOING PERITONITIS SINCE (B)(6) 2010. ON (B)(6) 2010, PERITONEAL DIALYSIS(PD) CULTURES WERE POSITIVE. ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH VANCOMYCIN AND MAXIPIME. THIS EPISODE OF PERITONITIS HAS BEEN ONGOING SINCE (B)(6). THE PD CULTURES WERE RETAKEN ON (B)(6) 2011 AND CULTURE WAS POSITIVE FOR ANOTHER ORGANISM. ON AN UNKNOWN DATE ANTIBIOTIC THERAPY WAS CHANGED TO VANCOMYCIN. THE PATIENT WILL COMPLETE ANTIBIOTIC THERAPY ON (B)(6) 2011. THE NURSE REPORTS THAT THE PATIENT'S CONDITION IS IMPROVED. SHE ALSO REPORTS THAT THE PATIENT'S PD THERAPY HAS BEEN ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ULTRA BAG DEXTROSE| DIANEAL LOW CAL| HOME CHOICE CYCLER