MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS MINI MOBILE SEAL DRAIN; BOTTLE, COLLECTION, VACUUM

Model Number 16400

Device Problems Gas/Air Leak (2946); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with a simple pneumothorax and a small bore catheter was inserted into the thoracic cavity.Doctor used a mini express 500 as the chest drain.50 ml of sterile water was added to the drain to evaluate for an air leak.Upon rotating the drain sideways, the fluid escaped through the suction tubing.Doctor also reported that the chest drain made a hissing noise when connected to suction.The confirmation check mark was visible but remained despite suction being discontinued.The mini express 500 was disconnected from the patient and replaced with an oasis 3600-100 chest drain.The patient did not have any ill effects.

Event Description

N/a.

Manufacturer Narrative

The unit was not returned, therefore the complaint could not be confirmed.Based on the details the physician added too much fluid to the drain when checking for an air leak.The instructions for use specify to use 20ml and the physician used 50ml.The hissing noise may have been created by the fluid being sucked up into the regulator after tipping the drain that caused the fluid to get sucked up into the vacuum line.All drains manufactured are tested for functionality prior to being packaged to ensure the product is working properly.A review of the device history records was performed confirming that this lot of express chest drains passed all quality and performance requirements.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 - 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.A check mark symbol is visible in the vacuum indicator window when vacuum is present inside the chest drain.When no vacuum is present inside chest drain, the check mark symbol will not appear.The check mark may take several minutes to disappear once suction has been discontinued while the system/body compensate for the change in pressure.The instructions for use (ifu) states that fluid must be present in the collection chamber for air leak detection.If fluid is not present, add 20 ml of sterile water or saline through the needleless luer port located on the front of the drain.Temporarily tip the drain to the right until collection fluid appears in the air leak window.Bubbling in the air leak window will confirm a patient air leak.Immediately return chest drain to upright position.

• Brand Name: EXPRESS MINI MOBILE SEAL DRAIN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9220890
• MDR Text Key: 163308353
• Report Number: 3011175548-2019-01124
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: 00650862164008
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Device Lot Number: 447064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention