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

Model Number 3600-100

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The clinical coordinator stated the floating ball does not move while on gravity and suction.Inquiring as to why the floating ball does not move while patient is breathing.

Event Description

N/a.

Manufacturer Narrative

The clinical coordinator has inquired as to why the oasis drain floating ball does not move while on gravity and suction or while patient is breathing.The drain was not available for return and evaluation.Two different videos were provided showing the drain in use.Both videos were reviewed in order to evaluate the cause of the reported complaint.The first video shows the chest drain being used on gravity as the bellows of the regulator was not open in the window.When the chest drain is operating under gravity, the ball will float up and down if that pressure is being transmitted down the tubing and into the drain.If that pressure differential is not seen in the water seal, it is likely because of an occlusion/blockage/catheter position.If there was a pneumothorax or leak then the float ball would be down and bubbling.There are no signs of positive pressure in the drain as there is no bubbling, no active pneumothorax or leak.In the second video, the chest drain is under vacuum as the bellows are pushing out.There is again no bubbling indicating that there is an air leak.The size or position of the catheter could cause the float ball to rise up and not 'tidal' with inhalation and exhalation.Again, there is no active air leak since there is no bubbling.The float ball reacts to pressures from suction and from the patient.Based on the videos and the details provided it is likely that the catheter used was blocked or not placed correctly.Based on the videos supplied by the complainant the drain is performing correctly, therefore the root cause of the reported complaint cannot be confirmed.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
• MDR Report Key: 11061313
• MDR Text Key: 223801445
• Report Number: 3011175548-2020-01497
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 66