BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1830310 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03098
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN DISCARDED BY THE CUSTOMER; THEREFORE A BAXTER EVALUATION WILL NOT BE PERFORMED. LOT NUMBER IS NOT KNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. PRODUCT CODE IS NOT KNOWN; THEREFORE A 510K CANNOT BE PROVIDED. (B)(4)

    Description of Event or Problem · 1

    BAXTER CLINICAL COST MANAGEMENT CONSULTANT PHONED IN A REPORT ON (B)(6), 2010 OF A FACILITY THAT HAD RECENTLY CONVERTED TO BAXTER SETS, SOLUTIONS, AND DRUG DELIVERY BACK IN (B)(6). THE FACILITY HAD AN INSTANCE WHERE THE BAG WAS SPIKED AND SETUP FOR AN INFUSION. THE FACILITY WAS USING AN UNKNOWN NS 1000 ML BAG, AND UNKNOWN BAXTER TUBING. THE CUSTOMER WAS ALSO USING AN INFU-SURG PRESSURE BAG (MANUFACTURED BY ETHOX INTERNATIONAL) WHEN THEY HAD THE TUBING EJECT OUT OF THE BAG. THIS REPORTED CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1