BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCULAR UNKNOWN DUMMY MATERIAL

    MDR report key: 6094172 · Received November 10, 2016

    Report

    Report Number
    1036844-2016-00583
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    May 1, 2014
    Report Date
    October 14, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD AN ADVERSE REACTION TO THE ARROWGARD CVC CATHETER AND THE PATIENT IS DECEASED. THE EVENT OCCURRED ABOUT A YEAR AND A HALF AGO. THE SALES REP HAS CONTACTED THE ANESTHESIA DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION. FOLLOW UP INFORMATION STATES A KIDNEY TRANSPLANT WAS BEING PERFORMED ON A (B)(6) MALE PATIENT. THE CATHETER WAS PLACED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR. ACCORDING TO THE ATTENDING ANESTHESIOLOGIST, THE PATIENT HAD NO KNOWN ALLERGIES PRIOR TO THE PROCEDURE. THE PATIENT RECEIVED MANY MEDICATIONS THROUGH A CENTRAL LINE AND PERIPHERAL IV BEFORE GOING INTO ANAPHYLACTIC SHOCK. CPR, FLUIDS, AND EPI WERE ADMINISTERED HOWEVER HE SUCCUMBED TO HIS INJURIES. FOLLOW UP INFORMATION STATES THE PRODUCT NUMBER IS UNKNOWN, HOWEVER, THE PHYSICIAN DID CONFIRM THAT IT WAS A COATED TRIPLE LUMEN CVC. IT WAS NOTED THE PHYSICIAN DID NOT SAY THAT THE ALLERGIC REACTION WAS CAUSED BY THE ARROW CATHETER. THEY CANNOT PIN POINT AS TO WHAT THE ACTUAL CAUSE WAS BECAUSE THEY WERE ALSO ADMINISTERING SEVERAL MEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744218 VASCULAR UNKNOWN DUMMY MATERIAL ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death