BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1893783 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05492
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 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 PATIENT DISCARDED 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 NURSE FROM (B)(6) OF DIARRHEA, FEVER, AND PERITONITIS IN PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, AND FEVER AND WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS DIARRHEA. DIANEAL PD4 UNKNOWN BAG THERAPY WAS ONGOING. THE PERITONITIS WAS RESOLVING. IT WAS UNKNOWN WHETHER THE DIARRHEA AND FEVER RESOLVED. THE REPORTER BELIEVED THE PERITONITIS WAS NOT RELATED TO DIANEAL PD4 UNKNOWN BAG THERAPY. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE DIARRHEA AND FEVER.

    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 28 YR Hospitalization| R DIANEAL PD4