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

Model Number 4000-100N

Device Problem Gas/Air Leak (2946)

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

Event Date 11/11/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that the chest drain wassetup and connected to the patient in accordance with the instruction for use.After connecting the suction line to the drain, the customer noticed a significant air leak as indicated by the air leak monitor.The surgeon confirmed with the anesthesiologist that there wasn¿t an air leak in the lung.

Event Description

N/a.

Manufacturer Narrative

The drain was not returned therefore an evaluation was unable to be performed.A review of the devise history records was performed and the lot of express chest drains passed all quality and performance criteria.All samples are 100% pressure tested during the manufacturing process.Based on the results of the investigation whereas the drain in question was not returned atrium medical corporation could not conclude that the chest drain in question was leaking.There is a possibility that there was a leak in the catheter attached to the patient line of the chest drain.We are unable to confirm this, as after multiple attempts to obtain more information and the unit was unsuccessful.Clinical evaluation: the express chest drainage system is intended to evacuate air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there were a loose connection between the patient and the drain.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.The instructions for use (ifu) states patient tube connections, air leak monitor, vacuum indicator, suction regulator and bellows should be checked regularly to confirm proper operation.The ifu also states users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: EXPRESS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8125005
• MDR Text Key: 129301551
• Report Number: 3011175548-2018-01432
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• 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: 12/03/2018

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 Expiration Date: 08/28/2021
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 434479
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1