BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1903750 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06039
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 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 NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENT. THE PATIENT WAS RECOVERING FROM THE EVENT.

    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 75 YR Hospitalization DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG