BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU-CLOSE THORACIC VENT

    MDR report key: 2061825 · Received April 5, 2011

    Report

    Report Number
    2061825
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 13, 2011
    Report Date
    April 5, 2011
    Manufacturer
    URESIL LLC
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT DEVELOPED A PNEUMOTHORAX DURING RECOVERY FROM A CT GUIDED BIOPSY OF LUNG MASS. INTERVENTIONAL RADIOLOGY PLACED THE URESIL TRU-CLOSE THORACIC VENT ON THE PATIENT. THE PATIENT WAS SENT TO THE FLOOR WITH A PINK SHEET "INFORMATION FOR PATIENTS AND NURSING" AND A PLASTIC BAG CONTAINING OBTURATOR AND TUBING. THE PATIENT DEVELOPED DIFFICULTY BREATHING THE NEXT MORNING. NURSING STAFF WAS NOT FAMILIAR WITH DEVICE WAITED FOR THE DOCTOR INSTEAD OF CLAMPING THE TUBING ON DEVICE. FOUR DAYS LATER PATIENT DEVELOPED A PNEUMOTHORAX. ON THE 8TH DAY IT COULD NOT BE RESOLVED WITH THE TRU-CLOSE. THE PATIENT HAD TO HAVE THE THORACIC VENT REMOVED AND ANOTHER CHEST TUBE INSERTED TO RESOLVE THE PNEUMOTHORAX. THE ISSUE WITH EDUCATION AND TRAINING NOT PROVIDED TO FLOOR NURSING STAFF OR PULMONOLOGISTS FOR DEVICE HAS BEEN SET UP BY CT STAFF. MEASURES ARE UNDERWAY TO EDUCATE NURSING AND PHYSICIAN STAFF.======================MANUFACTURER RESPONSE FOR THORACIC VENT (CHEST TUBE), TRU-CLOSE THORACIC VENT======================EDUCATION IS PLANNED FOR PHYSICIAN (PULMONOLOGISTS) OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-CLOSE THORACIC VENT THORACIC VENT (CHEST TUBE) KDQ URESIL LLC TV11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O| R