BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2042601 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04160
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH NUTRINEAL PD4, UNKNOWN BAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH NUTRINEAL PD4, UNKNOWN BAG THERAPY (2.5L, LOT NUMBER, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT RECEIVED REMEDIAL THERAPY, IF THE EVENT OF PERITONITIS RESOLVED, OR WHETHER NUTRINEAL PD4 UNKNOWN BAG THERAPY WAS ONGOING. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CONSUMER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS AND THE RELATIONSHIP WITH NUTRINEAL PD4 THERAPY. FURTHER INFORMATION HAD BEEN REQUESTED, HOWEVER, HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other NUTRINEAL PD4| HOMECHOICE