BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2143350 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08473
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4 INVOLVED WITH THIS ISSUE. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY. THIS IS ONE OF MULTIPLE REPORTS BY SAME REPORTER. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN THERAPY (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD) WITH THE HOMECHOICE (HC) DEVICE. ON (B)(6) 2011, THE NURSE REPORTED THAT SHE HAD A PATIENT (4 OF 4 TOTAL PATIENTS) WHO EXPERIENCED PERITONITIS AFTER SWITCHING TO THE NEW BAXTER LUERLOCK AND TUBING SETS. THE NURSE STATED THAT SHE BELIEVED THAT THE CAUSE OF THE PERITONITIS WAS POSSIBLY DUE TO THE NEW LUERLOCK AND TUBING SETS. IT WAS NOT REPORTED IF TREATMENT WAS RENDERED, IF DIANEAL UNKNOWN THERAPY WAS ONGOING, OR IF THE EVENT OF PERITONITIS RESOLVED. THE NURSE STATED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL UNKNOWN