BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3958927 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24333
    Event Type
    Death
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT "OAP" REFERS TO OEDEMA ACUTE PNEUMONIA. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED TIRED, ¿OAP¿, INFECTION SHOCK AND SUBSEQUENTLY PASSED AWAY DUE TO THE INFECTION SHOCK. ON AN UNREPORTED DATE, THE PT EXPERIENCED BEING TIRED AND ¿OAP¿ (UNKNOWN ABBREVIATION FOR UNKNOWN MEDICAL EVENT). SIX DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT WAS NOT REPORTED. FIVE DAYS LATER, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PT EXPERIENCED INFECTION SHOCK (NOT FURTHER SPECIFIED). TREATMENT WAS NOT REPORTED. ON THE SAME DAY AS BEING DISCHARGED FROM THE HOSPITAL, THE PT DIED DUE TO THE INFECTION SHOCK. DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF THE PT EXPERIENCED PERITONITIS DURING THIS EVENT. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438407 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H DIANEAL PD4, 2.5%| DIANEAL PD4, 1.5%