MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. OASIS DRY SUCTION WATER SEAL DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 08/12/2014

Event Type  Injury  

Event Description

A medwatch report was received.The report stated that a patient with right upper lobe adenocarcinoma with pleural effusion went to endoscopy for pleuroscopy of right thoracic wall.The chest tube was connected to dry suction water seal chest drainage system.The patient developed chest pain and it was discovered that oxygen at 15 liters per minute was connected to the drainage system in the area where suction should be applied to the unit.The drain system was bubbling at 20 cm.Suction was applied correctly within 2 minutes.Patient's chest pain resolved with drain system reading at 10 cm suction.Patient found to be in flash pulmonary edema 30 minutes later, admitted and was intubated for 6 hours.The patient was discharged home afterwards.Mw ref# 5038804.

Manufacturer Narrative

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

• Brand Name: OASIS DRY SUCTION WATER SEAL DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645366
• MDR Report Key: 4671043
• MDR Text Key: 5693252
• Report Number: 1219977-2015-00112
• 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: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: STAR HUMON TUBING
• Patient Outcome(s): Required Intervention