BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    MDR report key: 4112251 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32902
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 29, 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). ADDITIONAL INFORMATION: A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AN ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH DAMAGE NOTED TO THE HANDHOLD OF THE BOTTLES. THE REPORTED ISSUE WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTAINER OF CONCENTRATE FOR HEMODIALYSIS LEAKED DUE TO DAMAGE ON THE HANDHOLD OF THE BOTTLE. THIS WAS IDENTIFIED DURING INCOMING INSPECTION BY THE REPORTING FACILITY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 9 OF 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591658 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - SANTIAGO 14B0102

    Patients

    Seq Age Sex Outcome Treatment
    1