BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3070696 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09972
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A PATIENT PASSED AWAY. THE PATIENT'S FATHER CLAIMED THAT THE PATIENT MAY HAVE BEEN PROVIDED WITH AN INFECTED DIALYSIS TUBE WHILE IN THE HOSPITAL AND FELT THIS MAY HAVE CONTRIBUTED TO HIS SON'S DEATH. THE EXACT PRODUCT WAS NOT PROVIDED. THE FATHER DOES NOT WANT TO BE CONTACTED. THE FATHER DIDN'T GRANT PERMISSION TO CONTACT THE HEALTH CARE PROFESSIONALS. THE PROCESS STEP IS UNKNOWN. THERE WAS PATIENT INJURY AND INVOLVEMENT. MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172773 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death