MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS BRU DRAIN; DRAIN, DRY TOTAL RECOVERY W/AC

Model Number 3650-100

Device Problems Device Slipped (1584); Vibration (1674); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr's: 1219977-2017-00086, 1219977-2017-00087.

Event Description

Report received stated that the drains dry suction regulator seemed to be loose and not properly connected, and that part of the drain was vibrating.

Manufacturer Narrative

The drain was not returned so an evaluation of the actual unit could not be performed.There is no way to determine if the oasis chest drain was performing improperly.All chest drains are 100% vacuum pressure leak tested to ensure the integrity of the chest drain in process prior to packaging.If the suction regulator were loose the device would not have passed the vacuum pressure leak test.The product lot number was not provided, therefore a device history record review was unable to be performed.Because the oasis chest drain was not returned there is no way to determine the cause of the complaint.Functional testing of the drain would have been performed if the drain was returned to determine the cause of the complaint.Based on the details of the complaint atrium can find no fault with the product.Clinical evaluation: the oasis chest drain system is intended to evacuate air and /or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinum.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.The instructions for use (ifu) provide a thorough written and visual instruction for the clinician.Even with provided instructions for use it is essential for proper education and periodic review with all staff involved in the set up and use of a product helps to ensure confidence.

• Brand Name: OASIS BRU DRAIN
• Type of Device: DRAIN, DRY TOTAL RECOVERY 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: 6632879
• MDR Text Key: 77426039
• Report Number: 1219977-2017-00088
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1