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

Device Problem Component Missing (2306)

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

Event Date 11/15/2017

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

Fda medwatch (mw5073491) received stated that an atrium chest drain was opened and found to be missing the appropriate tubing to allow the chest tube to be connected to the new drainage system.

Manufacturer Narrative

The unit was received and inspected.The drain contained the in-line connector but not the actual tubing.The in-line connector is part of the tubing assembly, therefore it is unknown why the drain would contain the actual in-line connector without the rest of the tubing assembly.

Manufacturer Narrative

The drain was not returned for evaluation, therefore the actual complaint could not be confirmed.A picture of the drain was provided and the picture showed that the drain contained the in-line connector which is part of the tubing sub-assembly.It is very unlikely that the manufacturer assembler would add the in-line connector without the tubing assembly.All drains are 100% inspected prior to packaging to ensure all components have been assembled to the drain.The lot number of the drain was not provided, therefore a device history record review could not be performed.Clinical evaluation: the express drain is indicated for use in 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 also helps to facilitate postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.When a product is presented for use and found to be defective a second device must be located and prepared for use.

• 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: 7164526
• MDR Text Key: 96855466
• Report Number: 3011175548-2018-00023
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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