BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1911400 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06405
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW AND LABELING REVIEW WILL NOT 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 PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON AN UNREPORTED COURSE OF ANTIBIOTIC THERAPY (DOSE, FREQUENCY AND ROUTE NOT REPORTED). DIANEAL THERAPY WAS ONGOING. THE ROOT CAUSE OF THE PERITONITIS WAS REPORTED AS POOR ENVIRONMENT. THE OUTCOME OF THE EVENT OF PERITONITIS WAS ONGOING AND UNCHANGED. THE REPORTING NURSE STATED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY BUT WAS RELATED TO A POOR ENVIRONMENT.

    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 27 YR Hospitalization| R DIANEAL PD4