BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    MDR report key: 4110287 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32773
    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). (B)(6). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED TO BAXTER AND AN EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED, AND PHYSICAL DAMAGE WAS OBSERVED ON THE HANDHOLD OF THE BOTTLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON COMPLETION OF THE INVESTIGATION, THE DAMAGE OF THE BOTTLE WAS IDENTIFIED AS THE CAUSE OF THE REPORTED PROBLEM OF LEAK; HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK DUE TO DAMAGE IN THE PRIMARY CONTAINER OF A BICARBONATE CONCENTRATE. THE DAMAGE IS LOCATED ON THE HANDHOLD OF THE BOTTLE. THIS WAS FOUND DURING THE TIME THE PRODUCT WAS RECEIVED, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591625 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - SANTIAGO 14A0044

    Patients

    Seq Age Sex Outcome Treatment
    1