MAUDE Adverse Event Report: ATRIUM MEDICAL OASIS SINGLE DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem Dyspnea (1816)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that a chest drain was connected to the chest tube and the nurse observed that there was continuous air leaking.Surgeon decided to reopen the chest in operating theater preparation room, patient experienced shortness of breath while propped in a upright position, it was then noticed that there was a small hole in the oasis single tube.The drain was immediately replaced and there was no harm to the patient.

Manufacturer Narrative

The drain tube line was received and inspected and upon opening the returned package it was evident that the patient line had been cut.The cut area was evaluated under magnification and appears to have been cut with a sharp object.How the patient line was cut is unknown.The device history records associated with this lot have been reviewed and found to be complete and has met all finished good specifications.Clinical evaluation: the oasis chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there was a loose connection between the patient and the drain or if there had been damage to the tubing itself as in a puncture or clamp that perforated the tubing.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.The instructions for use (ifu) instructs do not puncture patient tube with an 18 gauge (1.27 mm) or larger needle.The thermoplastic elastomer may not properly close the puncture.This may open the pleural space to atmospheric pressure and compromise respiratory function.The ifu also states patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8256134
• MDR Text Key: 133481791
• Report Number: 3011175548-2019-00085
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 421863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1