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

Model Number 4000-100N

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/21/2018

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 patient tubing connected to the drain became easily disconnected.

Manufacturer Narrative

The drain was not returned for evaluation.Based on the details and correspondence with the institution the drain line became disconnected when it was either tripped over or tangled bedside.The drain line to the actual drain has a tensile strength requirement of 15lbs minimum.If this was exceeded during the activities surrounding the line being disconnected it is possible the seal was broken allowing bodily fluid to make its way into the connection.If this were the case, the bodily fluid acts like a lubricant allowing for an easy disconnection of the patient line from the body of the drain.During the manufacture of the drain the tubing is dipped in alcohol and pushed on to the drain connector.Upon drying the tubing creates a tight seal.On average the tensile strength of the drain line to the chest drain connector routinely exceeds over 20lbs of force.The instruction for use state that the following ¿always place chest drain below the patient¿s chest in an upright position.To avoid accidental knock-over, place the unit on the floor or hang it bedside with the hangers provided".Clinical evaluation: the express chest 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.A disconnect of the tubing of a chest drain during movement of the patient or during transfer from bed to chair may be the result of someone stepping on the tubing, the tubing becoming stuck under an object or by getting hung up on an object.Diligence and attention is required to protect the chest tube system during patient movement.

• Brand Name: EXPRESS DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7423510
• MDR Text Key: 105539219
• Report Number: 3011175548-2018-00358
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1