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

Model Number 2002-000

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event 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.

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
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8511950
• MDR Text Key: 142077094
• Report Number: 3011175548-2019-00389
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (y/n): N
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR