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

Model Number 3650-100

Device Problems Loose or Intermittent Connection (1371); Vibration (1674)

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: 1219977-2017-00087, 1219977-2017-00088.

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 returned device was received and inspected for damage.No damage was noted.The drain had been filled to the 2cm fill line as specified in the instructions for use (ifu).To determine the cause of the complaint and to try to recreate the issue as described in the complaint, the unit was prepared per the ifu.The regulator upon connecting to a vacuum source was set at -20cmh2o as shipped.No unusual noises were coming from the chest drain.The regulator was then slowly advanced to -40 cmh2o and again no unusual sounds were observed from the chest drain.The vacuum was released and the regulator set to its lowest setting of -10cmh2o.The vacuum line was then clamped using forceps pinching off the tubing by half its diameter.Again the vacuum was turned back on and the regulator cycled from -10cmh2o to -40cmh2o.No unusual sounds were noted.The complaint indicated that the regulator seemed loose.After cycling the regular during this evaluation the regulator was not loose and was performing properly.The chest drain when prepared following the ifu was unable to replicate the described vibrations or sounds specified by the institution.All drain regulators are tested on an automated regulator test unit in manufacturing to ensure the performance of the regulator.Based on the details of the complaint, atrium can find no fault with the functionality of the returned product and therefore cannot determine root cause of the complaint.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: 6632875
• MDR Text Key: 77425223
• Report Number: 1219977-2017-00086
• 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,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 Expiration Date: 03/31/2020
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Device Lot Number: 248576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1