BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    MDR report key: 3833924 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17129
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - SANTIAGO
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLASTIC BOTTLE FILLED WITH 10L BASIC HEMOCONCENTRATE WAS CONTAMINATED WITH MOLD. THE BOTTLE WAS FOUND TO BE DAMAGED AND CONTAINED BLACK SPOTS THAT RESEMBLED MOLD. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310717 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - SANTIAGO 13E0359

    Patients

    Seq Age Sex Outcome Treatment
    1