BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3830076 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16781
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.  SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER IT IS KNOW THAT THE EVENT OCCURRED IN THE ADULT INTENSIVE CARE UNIT. EXACT DATE OF EVENT IS UNKNOWN, HOWEVER IT WAS REPORTED THAT IT OCCURRED BETWEEN (B)(6) 2014. IF THE SAMPLE BECOMES AVAILABLE FOR EVALUATION OR ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD BACKFLOW WAS OBSERVED FROM A CENTRAL VENOUS CATHETER (CVC) TO A CLEAR LINK DUO VENT SET. THE REPORTER STATED THAT AFTER INFUSION OF LEVOPHED (NOREPINEPHRINE BITARTRATE) WAS STOPPED, THE ADMINISTRATION SET WAS KEPT CONNECTED TO THE CVC LINE, AND THE CVC LINE WAS KEPT UNCLAMPED. THAT IS WHEN BLOOD BACK FLOW WAS OBSERVED. THE EXACT AMOUNT OF BLOOD IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308293 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 LEVOPHED