BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV

    MDR report key: 1970551 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01003
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    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). 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 COMPLETED A DETAILED INVESTIGATION INTO THE OCCURRENCE OF WHITE PRECIPITATE IN SOLUTION LINES ASSOCIATED WITH THE USE OF ACCUSOL. IT HAS BEEN DETERMINED THAT THE REPORTED WHITE MATERIAL IS PRECIPITATION OF CALCIUM CARBONATES. BAXTER HAS AN ACTIVE TEAM WORKING ON IMPROVING THE PERFORMANCE OF THE ACCUSOL PRODUCT. THE INVESTIGATIONS HAVE DETERMINED THAT THE PH OF THE SOLUTION IS THE PRIMARY ROOT CAUSE OF THIS PROBLEM. THE HIGHER THE SOLUTION PH THE MORE LIKELY THE FORMATION OF PRECIPITATES. A REVISED SPECIFICATION FOR SOLUTION PH HAS BEEN IMPLEMENTED AND ONLY BATCHES THAT MEET A REVISED PH LIMIT OF 7.3 ARE RELEASED. THIS IS EFFECTIVE FROM (B)(6) 2008. BAXTER HAS WORKED WITH THE RELEVANT REGULATORY BODIES ON THIS SUBJECT AND ISSUED A CAUTION IN USE NOTIFICATION TO CUSTOMERS AND HOSPITALS OUTLINING APPROPRIATE ACTIONS TO TAKE WHEN PRECIPITATES ARE IDENTIFIED. ALSO, THE DIRECTION INSERT FOR THE PRODUCT HAS BEEN UPDATED TO PROVIDE ADDITIONAL USER INSTRUCTIONS. BAXTER CONTINUES TO WORK ON THE SOLUTION FORMULATION TO OPTIMIZE ITS PERFORMANCE AND REDUCE THE LIKELIHOOD OF PRECIPITATION FORMATION. A NUMBER OF DEFINITIVE ACTIONS ARE BEING CONSIDERED AND THESE ARE BEING REVIEWED WITH THE REGULATORY AUTHORITIES.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT WHILE A PATIENT WAS RECIEVING THERAPY, PRECIPITATION OF A WHITE SUBSTANCE WAS NOTICED BETWEEN THE PRE/POST DILUTION PUMPS. PATIENT WAS 48HRS INTO THERAPY BEFORE THE PRECIPITATION WAS NOTICED. THE BLOOD WAS RETURNED TO THE PATIENT, THERAPY WAS DISCONTINUED AND NEW TREATMENT STARTED. NO ADDITIONAL MEDICATION WAS INJECTED INTO THE ACCUSOL BAG OR ADDED THROUGH THE LINES. THE PATIENT WAS INVOLVED BUT NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10E11G70

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HEMODIALYSIS MACHINE