BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN CHEST DRAIN

    MDR report key: 10001319 · Received April 27, 2020

    Report

    Report Number
    3011175548-2020-00586
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 OCEAN CHEST DRAIN HAS TO THE REPORTED ADVERSE EVENTS. THE ARTICLE CONCLUDED NO SIGNIFICANT DIFFERENCE WAS OBSERVED WHEN THE DCD WAS COMPARED WITH THE CLASSIC SYSTEM. BASED ON THE INFORMATION AVAILABLE ATRIUM HAS DETERMINED THAT THE EVENTS DESCRIBED ARE NOT RELATED TO A PRODUCT FAILURE. DEVICE EVALUATED BY MANUFACTURER? NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ARTICLE RECEIVED TITLED THE BENEFITS OF DIGITAL CHEST DRAINAGE N PLEURAL DECORTICATION IN THORACIC EMPYEMA. PROSPECTIVE, RANDOMISED, CONTROL TRIAL. CIRUGIA Y CIRUJANOS, PP. 522-525. PURPOSE: THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTS OF PROLONGED AIR LEAK BETWEEN THE DIGITAL CHEST DRAINAGE (DCD) SYSTEM AND THE CLASSIC DRAINAGE SYSTEM IN PATIENTS WITH EMPYEMA CLASS IIB OR III (AMERICAN THORACIC SOCIETY CLASSIFICATION) IN PLEURAL DECORTICATION PATIENTS. METHOD: A TOTAL OF 37 PATIENTS WERE ENROLLED IN A PROSPECTIVE RANDOMISED CONTROL TRIAL OVER ONE YEAR, CONSISTING OF 2 BLINDED GROUPS, COMPARING PROLONGED AIR LEAK AS A MAIN OUTCOME, THE NUMBER OF DAYS UNTIL REMOVAL OF CHEST DRAIN, LENGTH OF HOSPITAL STAY AND COMPLICATIONS AS SECONDARY OUTCOMES. PER THE ARTICLE ADVERSE EVENTS INCLUDED: HEMOTHORAX, ATELECTASIS, PROLONGED AIR LEAK, PROLONGED FLUID LEAK AND RESIDUAL COLLECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464320 OCEAN CHEST DRAIN APPARATUS, AUTOTRANSFUSION CAC ATRIUM MEDICAL CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention