BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 4-LUMEN 8.5FR X 16CM

    MDR report key: 6173365 · Received December 14, 2016

    Report

    Report Number
    3006425876-2016-00391
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS PRODUCT IS NOT SOLD IN THE US. THE 510K # PROVIDED IS FOR A SIMILAR PRODUCT THAT IS SOLD IN THE US. NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DOCTOR THAT A SERIOUS INCIDENT OCCURRED TODAY WITH REGARDS TO A LIKELY AIR EMBOLISM IN THE UNIT ON A PATIENT WHO WENT PROFOUNDLY HYPOXIC AFTER A CVC INSERTION. THE CXR POST PROCEDURE DID NOT REVEAL A PNEUMOTHORAX AND HENCE WE RESORTED TO A TTECHO. THE ECHO REVEALED LOTS OF 'AIR BUBBLES' IN THE RIGHT HEART. WE DID MANAGE TO ASPIRATE ABOUT 10 - 20 MLS OF AIR OUT OF THE 200 MLS OF BLOOD DRAWN UP IN THE SYRINGES. HIS HYPOXIA GOT BETTER, AS DID THE MURMUR THAT DISAPPEARED POST ASPIRATION. ALTHOUGH THERE MIGHT BE OTHER CAUSES CONTRIBUTING TO HIS HYPOXIA, HE DID HAVE A VERY SUGGESTIVE (OF AIR EMBOLISM) PICTURE THAT IMPROVED WITH 'TEXTBOOK' ASPIRATION VIA CVC. WE WILL BE DOING A (B)(6) ALERT - GIVEN THE 'WHITE' BUNG HAS A HOLE IN THE MIDDLE. THE OTHER 'BLUE' BUNGS DO NOT HAVE ANY HOLES (AS NORMALLY HAPPENS)." THE DOCTOR POINTED OUT THAT THE STANDARD CVC SET USED ON THE UNIT DID NOT HAVE ANY OF THE WHITE VENTED CAPS ONLY THE BLUE CAPS AND THE DIFFERENCE BETWEEN THIS AND THE SET INCLUDED IN THE MSB PACK COULD GIVE RISE TO CONFUSION. THE DOCTOR ALSO INDICATED THAT IN HIS VIEW, THIS INCIDENT WAS NOT SOLELY ATTRIBUTABLE TO THE ARROW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824780 CVC KIT: 4-LUMEN 8.5FR X 16CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 71F16K1890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention