BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1792014 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02355
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. A LABELING REVIEW WAS CONDUCTED AND FOUND TO ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT.

    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 THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST AND THE PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS. A BREAK IN ASEPTIC TECHNIQUE WAS REPORTED. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE "PATIENT MADE A MISTAKE, DID NOT WEAR A MASK AND AREA NOT CLEAN BEFORE STARTING DIALYSIS." ON (B)(6) 2010 THE PATIENT WAS DIAGNOSED WITH PERITONITIS. NO CULTURE OR PERITONEAL EFFLUENT ANALYSIS WAS DONE. ON (B)(6) 2010 THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1GM, DAILY, IP) AND REFLIN (1GM, TID, IP). THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH REFLIN AND FORTUM CONTINUED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE OR IF IT RESOLVED.

    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 70 YR Required Intervention