BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1892535 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05423
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. 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

    IN (B)(6) 2010, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. LAB TESTS WERE NOT PERFORMED. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH REFLIN 1 GM ONCE DAILY INTRAPERITONEALLY (IP), TOBRAMYCIN 40 MG ONCE DAILY IP, AND HEPARIN 0.5 ML THREE TIMES DAILY IP. THE ROOT CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. THE PERITONITIS WAS RESOLVING. IT WAS UNKNOWN WHETHER THE BREAK IN ASEPTIC TECHNIQUE RESOLVED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER BELIEVED THE PERITONITIS WAS RELATED TO THE BREAK IN ASEPTIC TECHNIQUE. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 65 YR Required Intervention DIANEAL PD2 ULTRABAG