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

Model Number 3600-100

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physician reported issues during surgery with the chest tubes.He stated the chamber needs to be changed out at least twice and then a third time on the nursing floor.When the patient gets taken off of suction it shows an air leak which means the patient needs to stay another day.If the chest tube chamber gets changed it shows no air leak.So the issue is when the chest tubes are being taken off of suction they show air leaks when the patient really does not have one.

Manufacturer Narrative

Analysis: based on the details of the complaint provided the physician was not pleased that the drain showed air leaks when the drain vacuum line was shut off.Correspondence with the institution shows that multiple questions were made in an attempt to better understand the situation that the physician was experiencing, however, the response was the following: ¿this seems to be an isolated issue and the team does not feel a conversation is necessary at this point in time.¿ a review of the instructions for use (ifu) provides the following information in regards to disconnecting the oasis chest drain: ¿system disconnection clamp off patient tubes or all indwelling thoracic catheters prior to disconnecting chest drain from patient¿ the reason for clamping the patient line is to prevent opening the chest cavity to the atmosphere and potentially creating a pneumothorax.Conclusion: based on the details provided atrium medical corporation cannot conclude that the drain was faulty.It is likely that the drain was not clamped at the patient line as suggested within the ifu prior to turning off the vacuum source.H3 other text : not available for return.

• Brand Name: OASIS CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9993117
• MDR Text Key: 189359214
• Report Number: 3011175548-2020-00573
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention