BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4250338 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40424
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DISCONNECTION RESULTING IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE DUE TO THE PATIENT¿S TUBING DISCONNECTING FROM THEIR TRANSFER SET AFTER IT GOT CAUGHT ON SOMETHING. THE PATIENT WAS HOSPITALIZED ONE DAY AFTER ONSET OF THE PERITONITIS EVENT. ON THE SAME DAY AS ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. SIX DAYS AFTER HOSPITALIZATION THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THREE DAYS AFTER DISCHARGE, THE PATIENT WAS READMITTED FOR PERITONITIS. DURING HOSPITALIZATION, PD THERAPY WAS DISCONTINUED, THEIR PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. TREATMENT FOR THE RECURRING EVENT WAS UNKNOWN. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER AND WAS REPORTED TO BE RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736696 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 1.5% DIANEAL PD4 SINGLEBAG,| 2.5% DIANEAL PD4 SINGLEBAG,| 4.25% DIANEAL PD4 SINGLEBAG