BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951217 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00188
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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) MALE PATIENT, COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (LOT NUMBER 1009058, DOSE AND FREQUENCY WERE NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH INJECTION CEFTAZIDIME 1GM LOADING DOSE (ROUTE NOT REPORTED); INJECTION VANCOMYCIN 1GM (ROUTE AND FREQUENCY WERE NOT REPORTED); INJECTION CEFTAZIDIME 250MG (ROUTE AND FREQUENCY WERE NOT REPORTED); AND INJECTION HEPARIN 2ML (ROUTE AND FREQUENCY WERE NOT REPORTED). AT THE TIME OF THIS REPORT, THE ANTIBIOTIC THERAPY AND DIANEAL WERE ONGOING. THE CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. THE OUTCOME OF THE PERITONITIS WAS REPORTED AS RESOLVING. THE BAXTER-EMPLOYED NURSE REPORTED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 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 64 YR Required Intervention DIANEAL PD2 ULTRABAG