MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS BRU W/AC; APPARATUS, AUTOTRANSFUSION

Model Number 3650-100

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Emergency room used a oasis ats 3650-100 drain and says that the clinical team complained of lack of flow/drainage with the system.They did not replace the chest drain and continued to use it with no adverse patient effects.

Manufacturer Narrative

As the oasis chest drain was not returned atrium medical corporation cannot conduct a proper investigation of the physical drain.Without the actual drain in question the complaint cannot be confirmed.All chest drains are 100% pressure tested to ensure there are no system leaks prior to packaging.Based on the details of the complaint it is not know what settings the vacuum source was set to.The suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2o or greater.This cannot be confirmed without the actual drain that was used.Based on the results of the investigation and the details provided, atrium medical corporation cannot conclude that the device was at fault.

Event Description

N/a.

• Brand Name: OASIS BRU W/AC
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8761478
• MDR Text Key: 150128730
• Report Number: 3011175548-2019-00739
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other