MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. EXPRESS DRY SEAL CHEST DRAIN

Model Number 4000-100N

Device Problem Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Date 03/20/2015

Event Type  Injury  

Event Description

Report stated that a drain was attached to an intercostal catheter on a pt for a tension pneumothorax.The drain was initially swinging and bubbling but after 5 minutes there was no swinging and bubbling causing significant and severe pain and haemodynamic compromise for the pt.Manual aspiration was performed until a second drain was attached.

Manufacturer Narrative

We are in the process of performing the investigation and upon completion of the investigation a follow up report will be submitted.

Manufacturer Narrative

The drain was received and inspected.There was no indication of any fluids having been collected in the drain or tubing during use.The drain was functionally tested and functioned as designed with air flowing from the open patient line and through the air leak monitor when suction was applied.The drain line was clamped and air flow through the air leak monitor ceased, indicating there are no leaks in the drain or tube set.The suction indicator checkmark was visible in each instance indicating suction applied to the device.Root cause could not be determined.The drain has no failure mode within it that would cause it to cease functioning completely.Once functioning, the unit is mechanically simple enough to continue to function at the same level unless physically damaged in some way (drop/crack) which would be evident to the user.The most likely reason for the drain to become ineffective after being initially effective is a blockage/kink of occlusion in the patient tube or catheter.

Manufacturer Narrative

The actual product was not returned therefore a full investigation could not be completed.A device history record review was performed on the possible lot number of the device that was provided in the complaints report.The records indicate that the lot of drains met specifications.There is no mechanism within the drain itself that could become faulty and compromise the function of the device in removing fluids and air from the patient.Once functioning, the unit continues to operate at the same level.The most likely reason for the loss of function was a blockage in the patient tubing caused by clots or a kink and/or blocked/ineffective catheter due to occlusion of the catheter within the pleural space.The subsequent manipulation of the catheter and tubing during manual aspiration and reconnection of the new device may have cleared the blockage and/or the repositioned catheter, causing the second drain to be effective.

• Brand Name: EXPRESS DRY SEAL CHEST DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. coordinator ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4671185
• MDR Text Key: 5734465
• Report Number: 1219977-2015-00097
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 216440
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention