BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1954432 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00344
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    August 1, 2010
    Report Date
    December 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN AND EXTRANEAL VIAFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY FEVER, ABDOMINAL PAIN AND CLOUDY DIALYSATE. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. ON (B)(6) 2010, THE PERITONITIS AND FEVER RESOLVED, ALTHOUGH A FINAL OUTCOME WAS NOT PROVIDED. IT WAS NOT REPORTED IF PD THERAPY HAD CONTINUED. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY. FURTHER INFORMATION WAS NOT AVAILABLE AT THIS TIME.

    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 59 YR Hospitalization DIANEAL UNKNOWN AND EXTRANEAL VIAFLEX