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

Model Number 4000-100N

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/12/2018

Event Type  Injury  

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 nurse observed that the air leak monitor (chamber a) did not have enough water.The nurse added water and noticed that the water in the air leak monitor chamber went into suction monitor bellows (chamber e) and into the wall suction tube.The collection (chamber d) was observed to be filled with foam.

Manufacturer Narrative

The drain was not returned therefore an evaluation of the unit could not be conducted.Based on the details of the complaint it is possible that there was a large air leak either in the drain or the patient line connection that caused rapid bubbling in the air leak chamber.This may cause condensation within the air leak chamber and evaporation of the fluid in the air leak chamber.The report received stated that the water turned greenish around the area of the bellows for this to occur the drain most likely was either knocked over at some point or the water seal was filled from the suction port and not at the needleless luer port located on the back of the drain.All drains are tested in line during manufacture to ensure the functionality of the regulator.Without the drain in question this cannot be confirmed.The lot number was not provided so a device history record review was unable to be performed.The express drain is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It is also used to facilitate post-operative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.The instructions for use (ifu) instruct to always place chest drain below the patient¿s chest in an upright position and to avoid accidental knock-over, place the unit on the floor or hang it bedside with the hangers provided.It 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: 7402792
• MDR Text Key: 104566184
• Report Number: 3011175548-2018-00326
• Device Sequence Number: 1
• Product Code: CAC
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Other Device ID Number: 00650862115130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention