MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Mw5115379 report received stated: while the chest tube is connected to wall suction, constant bubbling is noted in the water seal chamber indicating an air leak when there is no actual air leak present.When the chest tube is removed from suction (placed to waterseal), the constant bubbling subsides and normal tidaling can be observed indicating there is not an air leak.This was observed on an atrium that was newly changed.The concern is if there is an issue with the internal pressure regulation of the atrium itself and with the ball being too low in the waterseal chamber/not floating properly.

Event Description

N/a.

Manufacturer Narrative

Additional information: section d10.

Event Description

N/a.

Manufacturer Narrative

Additional information: d9 & h6.Investigation: this complaint claims the customer set up a 3600-100 drain with wall suction and witnessed bubbling in the water seal chamber.When the drain was removed from the wall suction, the bubbling ceased and normal tidaling was seen, indicating the patient had no air leak.They are concerned that because there was bubbling in the water seal chamber while on wall suction, and because the ball was low in the chamber, there is an issue with the drain's internal pressure regulation.The customer returned an unopened drain from the same lot as the one they claim was defective.The returned drain was opened and set up.Water was added to the water seal chamber, up to the 2cm fill line.The drain was attached to a suction source which was set to -80 mmhg.The water in the water seal bubbled appropriately and the float ball lowered to the bottom of the chamber.When the patient line was clamped the bubbling subsided, indicating there was no air leak.The drain functioned properly.The dhr for lot 491419 was reviewed and no anomalies were identified.The dhrs and incoming inspection records of relevant parts were reviewed.Applicable equipment and procedures were reviewed.Design documents for the finished drain and applicable components were reviewed.No anomalies were identified to suggest that design or manufacturing are related to the cause of this complaint.The ifu provides adequate instructions for the setup and use of the device and contains all the information required to avoid this failure.No changes are needed to the ifu.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.This complaint reported that bubbling was seen in the water seal chamber and the float ball lowered in the chamber when a 3600-100 drain was connected to wall suction.The user was concerned that this indicates an air leak in the drain.The user returned another drain from the same lot which was evaluated and found to be functioning normally.No indication could be found in the trend review or dhr review that this is a systemic problem or that it is related to manufacturing.No evidence was provided to confirm the complaint or a device nonconformity.The root-cause of this complaint is impossible to define.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity cannot be confirmed with the provided information or with the information reviewed in this investigation.A definite root-cause cannot be determined.H3 other text : a device from same lot was evaluated.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16566374
• MDR Text Key: 312019274
• Report Number: 3011175548-2023-00075
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 491419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/27/2023; 05/04/2023
• Supplement Dates FDA Received: 03/30/2023; 05/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 14 FR PIGTAIL CHEST TUBE