BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2173544 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13596
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN UNKNOWN NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS IN WHICH THE ROLLER CLAMP IS NOT FUNCTIONING PROPERLY. ACCORDING TO THE REPORT, MULTIPLE NURSES IN THE PRE-OP/PACU DEPARTMENT OBSERVED THAT AFTER THE 2C8541 IS SET-UP(PRIMED) AND THE GRAVITY RATE IS ESTABLISHED ON A PATIENT DESTINED FOR THE O.R., AFTER FEW MINUTES THE RATE THAT WAS ESTABLISHED HAS INCREASED AND THE NURSES HAVE TO RE-ESTABLISH THE DESIRED RATE. THE CONDITION WAS IDENTIFIED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1