BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3192979 · Received June 27, 2013

    Report

    Report Number
    1416980-2013-16523
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID FLOWED CONCURRENTLY FROM BOTH THE PRIMARY AND SECONDARY BAGS, WHICH WERE CONNECTED TO A CLEARLINK DUO-VENT SOLUTION SET. THIS OCCURRED DURING PATIENT INFUSION USING AN UNKNOWN INFUSION PUMP. THE REPORTER STATED THAT THE HEIGHT OF THE BAGS WAS APPROPRIATE AND THAT THE BLUE HANGER WAS FULLY EXTENDED PRIOR TO USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294475 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1