BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1896808 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05580
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 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 PHYSICIAN FROM (B)(6) OF ASEPTIC PERITONITIS IN A PATIENT COINCIDENT WITH NUTRINEAL PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010 THE PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED ASEPTIC PERITONITIS (DATE, TIME OF ONSET AND DURATION NOT REPORTED). EVENT OUTCOME AND ACTION TAKEN WITH NUTRINEAL WERE NOT REPORTED. THE REPORTER'S ASSESSMENT OF CAUSALITY WAS POSSIBLE FOR THE EVENT AND NUTRINEAL. MULTIPLE REPORTS WERE RECEIVED FROM THE SAME PHYSICIAN.

    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 NUTRINEAL PD4 UNKNOWN BAG