BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2141655 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08957
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A LABEL REVIEW OF THIS PRODUCT CODE WAS CONDUCTED. THE LABEL WAS FOUND TO CONTAIN THE APPROPRIATE DIRECTIONS, CAUTIONS, AND NOTES. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET IN WHICH A BACKFLOW OCCURRED. ACCORDING TO THE REPORT, WHILE IRON WAS INFUSING VIA AN UNKNOWN PUMP, THE RN NOTICED THAT THE IRON WAS BACKING UP INTO THE PRIMARY SALINE BAG (APPROXIMATELY 60CC). THE CONDITION OCCURRED DURING INFUSION ON A PATIENT. 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 IRON