BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL 35 5L ACCUMOON(CZ/POL/SK/UK/IRL)

    MDR report key: 1909484 · Received November 29, 2010

    Report

    Report Number
    1423500-2010-06352
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 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. A BATCH REVIEW COMPLETED AND WAS ACCEPTABLE. A TREND REVIEW WAS COMPLETED AND THERE WAS NO SIGNIFICANT TREND. ANALYSIS OF SAMPLES FOR PREVIOUS COMPLAINTS FOR THIS ISSUE CONFIRMS THAT THE PRECIPITATES CONSIST OF CALCIUM CARBONATES. BAXTER HAS FOCUSED ON TIGHTER CONTROL OF THE SOLUTION MANUFACTURING PROCESS AND REDUCING MANUFACTURING VARIABILITY. 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. A CAUTION IN USE NOTIFICATION WAS ISSUED 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. A NUMBER OF DEFINITIVE ACTIONS ARE BEING CONSIDERED AND THESE ARE BEING REVIEWED WITH THE REGULATORY AUTHORITIES.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER (B)(4). THE COMPLAINT AN INCIDENT INVOLVING A ACCUSOL 35 5L ACCUMOON. THE REPORTER STATED THAT WHILST THE PATIENT WAS CONNECTED AND THE SET WAS IN USE FOR 35HRS PRECIPITATION WAS NOTICED POST HEATER COIL. NO PATIENT INJURY HAS BEEN REPORTED / CONFIRMED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL 35 5L ACCUMOON(CZ/POL/SK/UK/IRL) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10I06G71

    Patients

    Seq Age Sex Outcome Treatment
    1