MAUDE Adverse Event Report: ATRIUM USA OASIS DRY SUCTION WATER DRAIN SEAL; WATER SEAL DRAIN

Model Number 3600

Device Problems Misconnection (1399); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Chest Pain (1776); Pulmonary Edema (2020); Extubate (2402)

Event Date 08/12/2014

Event Type  Injury  

Event Description

On (b)(6)2014, a (b)(6) female patient with right upper lobe adenocarcinoma with pleural effusion went to endoscopy for pleuroscopy of right thoracic wall.Chest tube was connected to atrium dry suction water seal chest drainage system.Patient developed chest pain and it was discovered that oxygen at 15 l/min was connected to drainage system in the area where suction should be applied to the atrium unit.The ct system was bubbling at 20 cm.Suction was applied correctly within 2 minutes.Patient's chest pain resolved with ct system reading at 10 cm suction.Patient found to be in flash pulmonary edema 30 minutes later, admitted and was intubated for 6 hours.Patient was discharged to home on (b)(6)2014.Attending physician states the event was a combination of product use error that resulted in tubing mis-connection and failure of the atrium's positive relief valve that should have corrected the application of positive pressure.Tubing mis-connection involved the placement of oxygen tubing on the vacuum/suction port of the atrium device.Oxygen tubing and suction tubing look very similar.Furthermore, the oxygen tubing readily fits on the suction port without using any adapters or connector modification.(b)(4).Dates of use: (b)(6)2014.Diagnosis or reason for use: rt pleuroscopy/pleurex cath for metastic pleural effusion.Event abated after use stopped or dose reduced: yes.

• Brand Name: OASIS DRY SUCTION WATER DRAIN SEAL
• Type of Device: WATER SEAL DRAIN
• Manufacturer (Section D): ATRIUM USA; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 4206895
• MDR Text Key: 4981206
• Report Number: MW5038804
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 49