BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3850978 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-17973
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION SHOWED NO DEFECTS. THE DEVICE WAS CONNECTED TO AN IN-HOUSE SOLUTION BAG AND AN IN-HOUSE SECONDARY SET WAS CONNECTED TO THE TOP Y-SITE FOR FUNCTIONAL TESTING WITH NORMAL FLOW OBSERVED. THE REPORTED PROBLEM WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BACKFLOW ACROSS THE CHECK VALVE OF AN UNKNOWN PRIMARY SET DURING INFUSION. THE DEVICE WAS BEING USED IN A SETUP WITH AN UNKNOWN SECONDARY LINE AND UNKNOWN INFUSION PUMP. IT WAS REPORTED THAT WHEN THE INFUSION PUMP WAS TURNED ON OR OFF, ¿MEDICATION CONTINUED TO RUN FROM SECONDARY BAG TO PRIMARY BAG. FLUID WOULD THEN RUN FROM THE PRIMARY BAG TO PATIENT.¿ THE SECONDARY BAG HAD BEEN FILLED WITH POTASSIUM CHLORIDE. THE REPORTER STATED THAT THE THERAPY HAD BEEN SET TO RUN FOR 60 MINUTES; DUE TO THE BACKFLOW, THE PATIENT RECEIVED LESS THAN THE EXPECTED 10MEQ OF POTASSIUM CHLORIDE. IT WAS REPORTED THAT THE PRIMARY LINE WAS THEN CHANGED, AND THE SECONDARY MEDICATION RAN PROPERLY WITHOUT ANY BACKFLOW. THERE WAS NO 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
    329608 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CARTAGO

    Patients

    Seq Age Sex Outcome Treatment
    1 BAG OF POTASSIUM CHLORIDE| UNKNOWN SECONDARY LINE| UNKNOWN INFUSION PUMP