BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961955 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00686
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 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 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)(6) OF PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2010 THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX THERAPY, MOST RECENT LOT NUMBER S10H11016 (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX THERAPY, MOST RECENT LOT NUMBER 1010055 (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN 1 GRAM IP LOADING DOSE AND TAZIN 4.5 GRAMS INTRAVENOUSLY TWICE DAILY. THE CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. THE OUTCOME OF THE PERITONITIS WAS REPORTED AS RESOLVING. DIANEAL AND EXTRANEAL THERAPIES CONTINUED. THE NURSE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS AS RELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    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 65 YR Hospitalization| R