MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problems Air Leak (1008); Noise, Audible (3273)

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

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated at day 1 post of video assisted thoracic surgery (vats) patient on an oasis drain had no airleak observed until 11:30 am.The drain started making a constant loud buzzing sound.They thought it may have been due to the suction so they changed the tubing, and then the outlet the suction was coming from with no resolution to the problem.The drain was bubbling indicating an airleak but the patient was stable and x-ray was clear.They ended up changing out the entire drain for a new drain around 3.00pm and the noise stopped and the drain no longer bubbled.

Manufacturer Narrative

The unit was not returned for evaluation.From the complaint description it appears that the noise coming from the drain was the result of a high-flow rate of air passing through the regulator.All drain regulators are tested per an automated regulator performance test stated in mp002776, section 5.2.7, oasis/millennium chest drain assembly procedure.This reported event does not adversely affect the operation of the unit and has no effect on the patient.The probable cause for the noise coming from the drain is a result of high-flow air passing through the regulator.The noise does not affect the function of the drain or adversely affect the patient.

• Brand Name: OASIS DRAIN, DRY SINGLE W/AC
• Type of Device: OASIS DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5948259
• MDR Text Key: 54626731
• Report Number: 1219977-2016-00201
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR