MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN SINGLE DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number	2002-000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
Received a user facility report (# (b)(4)) that states the patient had a coronary artery bypass graft (cabg).When patient arrived to room and while setting up the chest tube suctions, a loud unknown noise was coming from the drain.No harm to patient reported.
Additional Manufacturer Narrative
The drain in question was not returned therefore atrium medical corporation cannot confirm the complaint.The lot number was not provided.An attempt to obtain more information regarding the drain was attempted.No other details were made available.Without additional information an investigation into the noise heard cannot be performed.Based on the results of the investigation atrium medical corporation cannot conclude that the chest drain was faulty.It is possible that the vacuum pressure was set too high.This cannot be confirmed without additional details.

• Brand Name: OCEAN SINGLE DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8511950
• Report Number: 3011175548-2019-00389
• Device Sequence Number: 16512407
• Product Code: CAC
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR