MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS PEDIATRIC DRAIN

Model Number 3612-100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pneumothorax (2012)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr 1219977-2015-00333.

Event Description

Report received stated patient had a pneumothorax.A drain was attached to the patient and only a bubble or two would come out of the air leak chamber and then would stop.Under x-ray it was observed that air was building up in the pleural space.The nurse unplugged the drain from the patient and air leak chamber was bubbling rapidly.They had to use a syringe to alleviate air from the pneumothorax being building up.The drain was being used with a 6fr pigtail catheter.

Manufacturer Narrative

Engineering evaluation: the unit was returned and evaluated.The returned drain was set-up and evaluated per the instructions for use (ifu) and standard procedures.The drains suction was set at -20 cmh2o and it measured within acceptable limits (-19.87 cmh2o).Conclusion: there were no issues found during the evaluation of the returned drain.The probable cause was most likely a blocked catheter caused by a clot or the catheter eyelets being against the chest wall.

• Brand Name: OASIS PEDIATRIC DRAIN
• Type of Device: OASIS PEDIATRIC DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5250759
• MDR Text Key: 32158435
• Report Number: 1219977-2015-00332
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3612-100
• Device Catalogue Number: 3612-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 1