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

Model Number 3600-100

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that a patient developed a tension pneumothorax, so a chest tube was inserted with dry seal chest drain.However, the patient worsened even when hooked up to suction and nursing and attending had confirmed the accordion was inflated.They changed out the drain without making any other changes and immediately saw resolution of patient's decompensation both clinically and via cxr imaging.

Event Description

N/a.

Manufacturer Narrative

This complaint claims that an oasis drain was set up on a patient with a vacuum source and the bellows inflated, indicating that suction was present; however, the patient developed a pneumothorax.The drain was swapped for another one that resolved the issue.The drain was returned to atrium for investigation without the patient tube.When received, the drain had some collected drainage fluid in it.Upon investigation, the drain was found to be functioning properly when set up correctly.Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device was non-conforming to it's specifications.The root-cause of this complaint is user error.A dhr could not be completed because the lot number was not provided.However, based on the description of the complaint and the results of the investigation, it is not believed that materials, equipment, or manufacturing processes are involved.The ifu for this device provides instructions for how to properly set up and use the drain.Complaint trending did not identify any excursions that require a corrective action request.The complaint history review identified three similar complaints, however two of those are believed to be caused by user error and the third was damage caused by supply chain handling (that kind of damage was not present on this drain).

• 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: 14842091
• MDR Text Key: 295055384
• Report Number: 3011175548-2022-00183
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention