BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1968203 · Received January 21, 2011

    Report

    Report Number
    1423500-2011-00921
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 29, 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. THE BATCH RECORD AND ANALYTICAL RESULTS FOR DIANEAL PD2 ULTRABAG, LOT NUMBER 1010022, HAVE BEEN REVIEWED AND FOUND TO BE COMPLIANT WITH STANDARD SPECIFICATION. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) OF PERITONITIS IN A (B)(6) OLD FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG, LOT NUMBER 1010022, (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1GM, LOADING DOSE, IP), ORZID (1GM, DAILY, IP), CEFIZOX (1GM, DAILY, IP), AMIKACIN (100MG, DAILY, IP) AND HEPARIN (500UNITS, IP). DIANEAL THERAPY WAS ONGOING. THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL 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 78 YR Hospitalization| R