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

Model Number 3600-100

Device Problem Decrease in Suction (1146)

Patient Problems Pneumothorax (2012); Blister (4537)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

While using the atrium oasis dry suction water seal chest drain on a patient it was noted that the suction failed.The devices was set to 20 cm h2o suction but appeared to have failed to provide suction to the chest tube.The patient was noted for increased subcutaneous emphysema to the anterior neck area.On cxr there was a right sided pneumothorax, where the chest tube was in place.The atrium oasis dry suction water seal chest drain was replaced and immediate air bubbling noted and patients 02 sats improved.On repeat cxr the pneumothorax was resolved.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint the physician had noted that there was no suction to the patient line when suction was applied.The devices was set to 20 cm h2o suction but appeared to have failed to provide suction to the chest tube.The returned device removed from the packaging and it was clear that this device had been used as there were still over approximately 100cc of plural fluid that had been left in the chest drain and was clearly collecting fluid at some point.This required the drain to be sanitized prior to any further investigation could be conducted.After cleaning the drain the front panel had a line scribed using a black pen or marker on the 180ml mark.This is usually how the staff knows how fast the drain is collecting by marking and timing the drain.This line shows that the fluid level at some point had presumably collected a 180ml of plural fluid.The patient lines were in good condition, the lines were wide open, not clamped, and there were no blockages.The drain was set-up and connected to a vacuum source and the drain operated utilizing the as received regulator setting of -20cm h2o.The regulator was then moved to the -30cm h2o setting.The output of the chest drain vacuum was measured and met the requirement for both settings and was in the acceptable range of -20 +2/-4 and -30 +3/-4 as described in drains and accessories product requirements document.The drain was able to draw suction to the patient line as expected which contradicts the reported complaint details, which indicated that no suction was noted when placed under suction.The lot number of the drain was not provided therefore a device history records review could not be conducted.Based on the investigation and the drain performing properly the complaint could not be confirmed.

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
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11572947
• MDR Text Key: 242769077
• Report Number: 3011175548-2021-00366
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention