BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN CHEST DRAIN

    MDR report key: 10000776 · Received April 27, 2020

    Report

    Report Number
    3011175548-2020-00583
    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
    ES
    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 THE DIGITAL THORACIC DRAINAGE SYSTEMS PROVIDE AN OBJECTIVE MEASUREMENT OF AIR LEAKAGE, ALLOWING EARLY CHEST TUBE REMOVAL AND DECREASING THE NUMBER OF RADIOGRAPHS PERFORMED POSTOPERATIVELY. ITS USE IN THE PEDIATRIC POPULATION APPEARS TO BE SAFE AND POTENTIALLY BENEFICIAL. BASED ON THE INFORMATION AVAILABLE ATRIUM HAS DETERMINED THAT THE EVENTS DESCRIBED ARE NOT RELATED TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED DIGITAL THORACIC DRAINAGE: A NEW SYSTEM TO MONITOR AIR LEAKS IN PEDIATRIC POPULATION. PURPOSE: THE OBJECTIVE OF OUR STUDY IS TO ANALYZE THEIR SAFETY AND EFFECTIVENESS IN THE POSTOPERATIVE PERIOD OF THE PEDIATRIC PATIENTS. METHOD: A PROSPECTIVE CONSECUTIVE OBSERVATIONAL STUDY WAS DONE. ALL PATIENTS SUBMITTED TO PULMONARY RESECTION BETWEEN 2011 AND 2017 AND IN WHOM DIGITAL THORACIC DRAINAGE SYSTEM WAS USED WERE PROSPECTIVELY ENROLLED IN THIS STUDY. PER THE ARTICLE ADVERSE EVENTS INCLUDED: PERSISTENT AIR LEAKAGE REQUIRING BLOOD PLEURODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463327 OCEAN CHEST DRAIN APPARATUS, AUTOTRANSFUSION CAC ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention