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

Device Problem Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 product family name and lot number where 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.

Event Description

N/a.

• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8511980
• MDR Text Key: 142079339
• Report Number: 3011175548-2019-00388
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• 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

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR