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

Model Number	3650-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem 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.
Additional 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 or Problem Description
N/a.

• Brand Name: OASIS BRU W/AC
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8761478
• Report Number: 3011175548-2019-00739
• Device Sequence Number: 14094833
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other