BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3943547 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23200
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT PASSED AWAY DUE TO PERITONITIS AND SEPTIC SHOCK. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND SUBSEQUENTLY PASSED AWAY DUE TO AN UNKNOWN CAUSE. ON THE SAME DAY AS THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED DUE TO EXPERIENCING ABDOMINAL PAIN. ON AN UNREPORTED DATE, THE PT WAS DIAGNOSED WITH PERITONITIS. TREATMENT FOR THE PERITONITIS WAS UNKNOWN. SUBSEQUENTLY THE PT PASSED AWAY DUE TO AN UNKNOWN CAUSE. IT WAS UNKNOWN WHETHER THE PT RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING DURING THE HOSPITALIZATION OR UNTIL THE TIME OF DEATH. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422738 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H DIANEAL PD4, 2.5% AMBUFLEX| DIANEAL PD4, 4.25% AMBUFLEX