BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1900607 · Received November 16, 2010

    Report

    Report Number
    1423500-2010-05817
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 22, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    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 7.3 ARE RELEASED. THIS IS EFFECTIVE FROM AUGUST 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 AN INCIDENT THAT WAS RECEIVED FROM A STAFF NURSE. THE PATIENT COMMENCED THERAPY WITH ACCUSOL 35 5000ML. ALL 4 BAGS OF ACCUSOL WERE MIXED AND WERE CONNECTED TO THE CRRT MACHINE. AFTER THERAPY WAS STARTED PRECIPITATION WAS OBSERVED BETWEEN DEGASSING CHAMBER AND PREDILUTION PUMP AND AFTER PREDILUTION PUMP. NO SPECIFIC ALARM WAS NOTICED BEFORE THE EVENT. AFTER IDENTIFICATION OF THE PRECIPITATION THE TREATMENT WAS DISCONTINUED. NO SAMPLE IS AVAILABLE FOR EVALUATION.

    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