BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1903693 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06006
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 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 PATIENT WAS (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. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF DIARRHEA, FEVER AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN, CLOUDY SOLUTION AND FEVER. THE CAUSE OF THE PERITONITIS WAS DIARRHEA. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLIN 1G X 2G/DAY AND GENTAMYCIN 40MG X 80MG/DAY (ROUTE AND DATES NOT SPECIFIED). PD THERAPY WAS ONGOING. THE PERITONITIS WAS ONGOING AND IMPROVED.

    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 Hospitalization| R DIANEAL PD4 ULTRABAG