MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS DRY SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 4050-100N

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.Device not returned.

Event Description

Received a report that device would not drain correctly.Unit was discarded because of blood being in the bottle.

Manufacturer Narrative

As the drain in question was not returned an evaluation of the actual product in question was unable to be conducted.Additionally none of the questions that were asked of the institution nurses or staff were answered.The details are not specific about the reasons why the drain was not draining properly.Without more specific details an investigation into the cause of the complaint is difficult to determine.There is a possibility that the vacuum source at the institution was not working properly.This cannot be confirmed.All drains manufactured are tested for functionality prior to being packaged to ensure the product is working properly.As the device lot number was not provided a review of the device history records could not be performed.Atrium medical corporation only releases product that has passed all quality and performance requirements.Based on the results of the investigation atrium medical corporation cannot conclude that the chest drain in question was the cause of the complaint.Clinical evaluation: a chest tube may not drain if the tubing becomes clotted or occluded, if the tubing has become dislodged or loosened, if the drain has reached its collection capacity or if the drain is not placed below the level of the chest.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) states water seal and suction control chambers must be filled to prescribed levels prior to use and should be checked regularly to confirm proper operation.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: EXPRESS DRY SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9105555
• MDR Text Key: 165314592
• Report Number: 3011175548-2019-01015
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862115147
• UDI-Public: 00650862115147
• 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
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4050-100N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1