BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - DRUG

    MDR report key: 2029923 · Received March 25, 2011

    Report

    Report Number
    1423500-2011-03702
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE HAS BEEN DETERMINED TO BE USER ERROR. THE LABELING REVIEW INDICATES THAT THE PRODUCT LEAFLET PROVIDES AMPLE INFORMATION ON USE AND CLEARLY INSTRUCTS THE USER TO BREAK THE INTER-CHAMBER SEAL PRIOR TO USE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING THE PRODUCT INVOLVED IN THE INCIDENT IS UNKNOWN. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) WHO REPORTED THAT THE SPIKE HAD BEEN INSERTED IN THE BICARBONATE CHAMBER OF THE PRODUCT ACCUSOL, BUT ALL OF THE SOLUTION INFUSED WITHOUT BEING MIXED. THE PATIENT GOT UNMIXED SOLUTION AND THE PATIENT BECAME ALKALINE. INTERVENTION FOR THE PATIENT WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other