BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1955414 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00386
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    May 1, 2010
    Report Date
    December 17, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) (LOCAL REFERENCE NUMBER (B)(4)) OF ASEPTIC PERITONITIS IN AN (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD1 1.36% AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD1 1.36% AND NUTRINEAL PD4 UNKNOWN BAG (DOSE, FREQUENCY, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT EXPERIENCED ASEPTIC PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN 500 MG AND ROCEPHINE 250 MGS FOR 1 DAY (ROUTE NOT REPORTED). THE PATIENT WAS THEN TREATED WITH VANCOMYCIN 60MG AND ROCEPHINE 125 MG PER BAG, 2 BAGS DAILY FOR 12 DAYS. ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM THE ASEPTIC PERITONITIS. IT WAS UNKNOWN IF PD THERAPY HAD CONTINUED. THE NURSE BELIEVED THE EVENT OF ASEPTIC PERITONITIS WAS POSSIBLY RELATED TO DIANEAL AND NUTRINEAL 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 88 YR Required Intervention DIANEAL PD1 1.36% AND NUTRINEAL PD4.