BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972289 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01156
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 4, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 NURSE FROM (B)(6) OF SOLUTION CHANGING TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. IN (B)(6) 2006, THE PATIENT BEGAN DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND WAS HOSPITALIZED. IT WAS NOT REPORTED IF A SAMPLE OF PERITONEAL EFFLUENT WAS ANALYZED OR IF REMEDIAL THERAPY WAS PRESCRIBED. THE ROOT CAUSE OF THE PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS WAS THE SOLUTION CHANGING TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THE PATIENT'S CONCOMITANT MEDICATION WAS NOT REPORTED. THE NURSE BELIEVED THE PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS WAS NOT RELATED TO DIANEAL PD4 ULTRABAG 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 46 YR Hospitalization| R