BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4220528 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38488
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE DUE TO ¿GENERAL HYGIENE DEFICIENCY¿ AND ¿MEDICAL CONDITIONS/TREATMENTS¿. THE CAUSE OF THE PERITONITIS EVENT IS BEING CONSERVATIVELY ASSESSED AS UNKNOWN AS THE CAUSE COULD NOT BE CONFIRMED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT¿S NON-BAXTER (PD) CATHETER WAS NOT FUNCTIONING AS INTENDED. THE PATIENT UNDERWENT SURGERY TO PLACE A HEMODIALYSIS CATHETER. THE CAUSE OF DEATH WAS DUE TO HEMODIALYSIS (HD) CATHETER INSERTION SURGERY. IT WAS NOT REPORTED IF THE PATIENT RECOVERED FROM PERITONITIS PRIOR TO DEATH. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703185 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| R TRANSFER SET, CASSETTE,| DIANEAL PD4 1.36% AND EXTRANEAL, HOMECHOICE