BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2220726 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11102
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED FOR THE DEVICE. THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CURRENT LABELING FOR WAS FOUND TO BE SUFFICIENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY. ON AN UNREPORTED DATE IN 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. THERAPY WITH DIANEAL UNKNOWN WAS ONGOING. THE NURSE STATED THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM WAS NOT RELATED TO DIANEAL UNKNOWN THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL UNKNOWN