BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2973943 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04442
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED AND NO CAUSE COULD BE DETERMINED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, A LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. TREATMENT RENDERED WAS NOT REPORTED. THE PATIENT EXPERIENCED INTERNAL BLEEDING INDUCED SEPSIS AND DIED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. BAXTER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78460 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| R DIANEAL PD2| EXTRANEAL WITH 7.5% ICODEXTRIN