BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133950 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07849
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO SOLUTION BAGS WERE RECEIVED AS SAMPLES. THE EVALUATED UNITS WERE FOUND TO BE ACCEPTABLE. THE ROOT CAUSE OF THIS WAS NOT DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A NURSE FROM (B)(6) REPORTED THAT WHILE PERFORMING CONTINUOUS VENO-VENOUS HEMODIALYSIS ON A PATIENT PRECIPITATE WAS OBSERVED AND HAD FORMED IN THE PREDILUTION LINE ONLY (NOT OBSERVED IN ANY OTHER LOCATION). WHITENING OF THE POST DILUTION COULD ALSO BE OBSERVED. (B)(4). THE TREATMENT CONTINUED. A SAMPLE OF THE PREDILUTION FLUID WAS TAKEN. THERE WAS NO PATIENT/USER/OTHER PERSON'S INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) PRODUCTCODE KPO BAXTER HEALTHCARE - CASTLEBAR 08B06G70

    Patients

    Seq Age Sex Outcome Treatment
    1