MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN SINGLE DRAIN; BOTTLE, COLLECTION, VACUUM

Model Number 2002-000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Report received stated that when the nurse checked on patient it was noticed that there was no water in suction chamber of the chest drain.No injury reported.

Event Description

N/a.

Manufacturer Narrative

The hospital did not save this event sample, however they did send back two other drains.The drain received still had small amounts of plural fluid still within the drain.The drain was disinfected prior to the evaluation of functionality.The chest drain once disinfected was inspected for cracks or damage.There were no signs of damage noted on the drain received.The drain was then set up per the instructions for use to determine if there were any leaks and for proper functionality.The water seal chamber was filled to the 2cm line on the drain and the suction control chamber filled to the -20cm per the instructions for use.A vacuum line was then added to the suction port of the chest drain.The drain was fully functional and bubbling was noticed in the water seal chamber.A clamp was then placed on the patient line of the drain and the bubbling completely stopped as expected with a properly functioning drain.The returned drain did not show any signs of leakage during the process of operation.An important note is that all chest drains manufactured are 100% tested to ensure that the device has no leaks.A review of the device history records for the chest drain was conducted to ensure there were no non-conformances during the manufacture of the drain related to the complaint.There were no non conformances noted that related to the complaint.The lot history records show that the chest drain leak test vision system was properly set up and functioning prior to starting the manufacturing build.The review also shows that the product lot number had a total of 3,510 units produced.A review of the complaint log indicates that this lot of chest drains did not have any complaints cited by any other institution going back to the manufacturing dates listed within the device history records august 2019 to the current date of 13 may 2020.Based on the physical and functional testing performed atrium medical corporation cannot confirm that the drain was in any way leaking or functioning improperly.The correspondence with the institution suggests that if the drains were not set up properly or left unattended for long lengths of time allowing the water seal fluid to evaporate especially when the suction control chamber is filled to lower levels and the vacuum was not controlled.The precautions section of the instructions for use (ifu) states the following: water seal and suction control chambers must be filled to prescribed levels prior to use and should be checked regularly to confirm proper operation.Patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.Summary/conclusion - based on the details provided and the evaluation of the similar device returned atrium medical corporation cannot conclude that the drain was faulty.It is likely that the drain was not set up properly or left unattended for long lengths of time allowing the water seal fluid to evaporate especially when the suction control chamber is filled to lower levels and the vacuum not controlled.H3 other text : dev ice not returned.

• Brand Name: OCEAN SINGLE DRAIN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9863748
• MDR Text Key: 189359334
• Report Number: 3011175548-2020-00449
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (y/n): N
• PMA/PMN Number: K043582
• 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: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1