BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133915 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07850
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 6, 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

    THE SAMPLE IS NOT AVAILABLE AT THIS TIME. THE ROOT CAUSE FOR THIS REPORTED EVENT IS UNDETERMINED, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT.

    Description of Event or Problem · 1

    A NURSE FROM (B)(6) REPORTED THAT WHILE PERFORMING CONTINUOUS VENO-VENOUS HEMODIALYSIS ON A PATIENT THE OBSERVED A CLOUDY APPEARANCE HAD FORMED IN THE PREDILUTION LINE ONLY (NOT OBSERVED IN ANY OTHER LOCATION). (B)(4) ACCUSOL WERE HANGING AT A TIME AND ALL BAGS HAD BEEN MIXED. NO MEDICATION WAS ADDED VIA THE AQUALINE (APART FROM HEPARIN VIA THE SYRINGE DRIVER). THE TREATMENT WAS STOPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 08D05G70

    Patients

    Seq Age Sex Outcome Treatment
    1