BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS CHEST DRAIN

    MDR report key: 9991725 · Received April 23, 2020

    Report

    Report Number
    3011175548-2020-00565
    Event Type
    Injury
    Date Received
    April 23, 2020
    Report Date
    April 23, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS REPORT AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. IT IS NOT KNOWN WHAT RELATIONSHIP THE OASIS CHEST DRAIN HAS TO THE REPORTED ADVERSE EVENTS THE ARTICLE CONCLUDED DIGITAL DEVICES DID NOT RESULT IN REDUCED CHEST TUBE DURATION OR HOSPITAL LENGTH OF STAY. BASED ON THE INFORMATION AVAILABLE ATRIUM HAS DETERMINED THAT THE EVENTS DESCRIBED ARE NOT RELATED TO A PRODUCT FAILURE. NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED DIGITAL AIR LEAK MONITORING FOR LUNG RESECTION PATIENTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL. PURPOSE: THE OBJECTIVE OF THIS STUDY WAS TO COMPARE DIGITAL AND ANALOG DEVICES IN PATIENTS UNDERGOING ANATOMIC LUNG RESECTION. METHOD: A SINGLE-INSTITUTION RANDOMIZED TRIAL WAS CONDUCTED. PATIENTS UNDERGOING ANATOMIC LUNG RESECTION BETWEEN NOVEMBER 2013 AND JULY 2016 WERE RANDOMIZED TO DIGITAL OR ANALOG DEVICES. CONCLUSION: DIGITAL DEVICES DID NOT RESULT IN REDUCED CHEST TUBE DURATION OR HOSPITAL LENGTH OF STAY. PER THE ARTICLE ADVERSE EVENTS INCLUDED, INCREASING PNEUMOTHORAX, SUBCUTANEOUS EMPHYSEMA, AIR LEAK, CHEST TUBE REINSERTION, EMPYEMA AND HEMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455779 OASIS CHEST DRAIN APPARATUS, AUTOTRANSFUSION CAC ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention