BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1871869 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04505
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Product Code
    KDJ
    Removal / Correction Number
    2010-060-RN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT OF PERITONITIS WAS REPORTED WITH THE USE OF NUTRINEAL. THE NUTRINEAL HAS BEEN IDENTIFIED AS THE CAUSE OF THIS PERITONITIS. THE NUTRINEAL LOT NUMBER INVOLVED IN THIS INCIDENT (10G12G44) IS ONLY DISTRIBUTED IN EUROPE AND HAS BEEN WITHDRAWN FROM THE MARKET DUE TO COMPLAINTS OF STERILE PERITONITIS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT WITHOUT ABDOMINAL PAIN. ON THIS SAME DATE, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFTAZIDIME 1G INTRAPERITONEAL (IP) DAILY AND VANCOMYCIN 2G IP DAILY FOR PERITONITIS. ON THIS SAME DATE, A SAMPLE OF PERITONEAL EFFLUENT WAS CULTURED. THE CULTURE RESULT REVEALED NO GROWTH. ON (B)(6) 2010, THE PATIENT STOPPED TAKING VANCOMYCIN, CONTINUED TAKING CEFTAZIDIME AND BEGAN TAKING CEFAZOLIN 1G IP DAILY. ON AN UNREPORTED DATE IN (B)(6) 2010, THE EVENT OF PERITONITIS RESOLVED. THE ROOT CAUSE OF THE PERITONITIS WAS NOT REPORTED. PD THERAPY CONTINUED UNCHANGED. THE NURSE REPORTED THAT THE PATIENT HAD NO HEART DISEASE OR DIABETES. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE COULD NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    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 39 YR Required Intervention