BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3080380 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10490
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS, PROLAPSE OF HER UTERUS AND EXIT SITE INFECTION IN A (B)(6) FEMALE PATIENT COINCIDENT WITH PHYSIONEAL 40 AND EXTRANEAL THERAPIES FOR END STAGE RENAL DISEASE (ESRD). ACTION TAKEN WITH PHYSIONEAL AND EXTRANEAL THERAPIES WERE NOT REPORTED. A CLOUDY BAG WAS REPORTED AND THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS. THE PATIENT WAS DIAGNOSED WITH PROLAPSE OF HER UTERUS AND THE BAG WAS STILL CLOUDY. ON AN UNREPORTED DATE, THE REPORTER STATED THAT THERE WAS A WORSENING OF PROLAPSE FROM SOLO CAPD BAGS, WHICH IMPROVED WITH A DRY DAY ON AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, VANCOMYCIN, CIPROFLOXACIN AND GENTAMICIN (DOSAGES, FREQUENCIES AND ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS ALSO TREATED WITH FLUCLOXACILLIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED). THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182653 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention HOMECHOICE, PHYSIONEAL 40 AND EXTRANEAL