BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1845049 · Received September 27, 2010

    Report

    Report Number
    1423500-2010-03747
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 3, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE 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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THE ROOT CAUSE FOR THE PERITONITIS IS UNDETERMINED AS NO SAMPLE WAS AVAILABLE FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1GM, LOADING DOSE ONCE IN A WEEK, IP), FORTUM (250MG, TID, IP), TOBRAMYCIN (20MG, TID, IP) AND HEPARIN (1000 UNITS, TID, IP). PD THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH VANCOMYCIN, FORTUM, TOBRAMYCIN AND HEPARIN. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO PD THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DIANEAL PD2 ULTRABAG