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

Model Number 3600-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician, when installing the oasis box presents continuous bubbling inside the water seal box, even when the patient drain is clamped.

Manufacturer Narrative

Related mdr: 3011175548-2021-00406.Based on the details of the complaint when installing the oasis drain the physician verified a leak showing bubbling inside the water seal of the drain, so it was changed for a new one.It was also stated that a clamp as placed on the tubing and it still leaked.Multiple questions were asked to better understand the details of the complaint without any success.The drain was also not returned for evaluation and no images of the chest drain were received.Based on the details provided the water seal chamber had bubbling.This is considered normal operation if the patient has air in the chest cavity.This can also be attributed to the connection of the patient line to the chest tube that is placed into the chest cavity.Depending on the placement of the catheter there can also be a leak created where the chest tube enters the patient.Dependent of the location of the clamp air could still be getting through the clamp if not properly applied or at a connection point to the patient line.Without the chest drain being returned, there is no way to determine if the oasis chest drain itself was at fault.During the process of manufacturing every drain is 100% vacuum pressure tested to ensure there are no leaks in the system.If a leak is detected during manufacturing, the device is scrapped.This testing is conducted following manufacturing procedure (automated leak vision testing).Prior to starting each lot of drains the vacuum leak check equipment is set up per the chest drain leak test vision system start up and setup procedure.During the set up and start up the equipment is tested using leak standards to ensure the system is detecting the proper leak rate.A review of the device history records shows that this production lot of oasis chest drains passed all quality and performance criteria and there were no non conformances noted during the manufacture of the product.This includes the review of the results of the leak check data.The device history records also show that the amount of drains produced under manufacturing lot number (454333) was 3,510 chest drains and there have been no other complaints related to this lot.The drains are bulk-packaged (six to a box) there is a possibility that the bulk-packaged box was damaged at some point after leaving the site of manufacture but this cannot be determined without the drain for evaluation or images provided.The reason for the bubbling in the water seal chamber is expected when there is an air leak with either of the connections to the drain, connections to the patient or if the drain was damaged.Based on the product not being returned for evaluation and no further details available the complaint cannot be confirmed.H3 other text : product not available.

Event Description

N/a.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11653904
• MDR Text Key: 250187270
• Report Number: 3011175548-2021-00405
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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 Expiration Date: 01/10/2023
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 454333
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/09/2021
• Patient Sequence Number: 1
• Patient Age: 87 YR