BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1936302 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07172
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE PRODUCT USED IS UNKNOWN AND THEREFORE THE 510(K) ENTRY FIELD IS LEFT BLANK. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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 DIARRHEA AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR ESCHERICHIA COLI (E. COLI). ON AN UNREPORTED DATE, THE PATIENT DEVELOPED DIARRHEA AND WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS DIARRHEA. ON AN UNKNOWN DATE, THE DIANEAL THERAPY WAS DISCONTINUED AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE DIARRHEA.

    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 61 YR Required Intervention DIANEAL PD4 ULTRABAG