BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1920438 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06782
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. 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.

    Description of Event or Problem · 1

    THIS IS AN INCIDENT THAT WAS RECEIVED FROM A NURSE. THE PATIENT COMMENCED CVVH (HAEMOFILTRATION) WITH ACCUSOL 35 5000ML. THE THERAPY SETTINGS WERE BLOOD FLOW 200ML/H, PREDILUTION 1500ML/H, POSTDILUTION 2000ML/H AND THE TEMPERATURE WAS 37 DEGREES C. KCL 20MMOL DOSE WAS ADDED TO THE ACCUSOL BAGS BUT NO MEDICATION WAS ADDED THROUGH THE LINES. PRECIPITATION WAS OBSERVED BETWEEN DEGASSING CHAMBER AND PREDILUTION PUMP, AFTER PREDILUTION PUMP AND AFTER POSTDILUTION PUMP. NO ADVERSE EVENTS/CONSEQUENCES WERE NOTED DURING THE PERIOD THAT THE PRECIPITATION FORMED. NO SPECIFIC ALARM WAS NOTICED BEFORE THE PRECIPITATION. WHEN THE PRECIPITATION WAS OBSERVED THE TREATMENT WAS DISCONTINUED AND THE DOCTOR WAS INFORMED.

    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 10I11G71

    Patients

    Seq Age Sex Outcome Treatment
    1