MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DUEL COLLECTION CHEST DRAIN; OASIS DRY SUCTION WATER SEAL CHEST DRAIN

Model Number 3620-100

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 12/09/2015

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's: 1219977-2015-00344, 1219977-2015-00345, 1219977-2015-00346, 1219977-2015-00348.

Event Description

Report received stated that wall suction was applied the patient in the intensive care unit (icu).After the patient was moved from icu to ward, the patient took gravity drainage and/or suction drainage by mobile suction device.Patient developed into pneumothorax and/or pneumomediastinum during ward care.

Manufacturer Narrative

Engineering analysis: no units were returned for evaluation.Connecting two patient tubes from the same drain to two different sections of the chest cavity (pleural and pericardial spaces) without suction (gravity drainage), will result in transfer of air from one space to the other (boyles' law) and would not be effective in removing air from either section.The portable suction unit identified is a low vacuum/low flow unit not suitable for chest drainage.The instruction for use (ifu) indicates a minimum suction level of -80 mmhg but the vario 8 only produces a maximum level of -68 mm hg and at a low flow rate.A lack of adequate suction resulted in equilibrium establishing itself between the two spaces and air entering the pericardium.If the unit were used under adequate suction as written in the ifu, -80 mmhg or greater, the air would have been effectively removed from both sections.

• Brand Name: OASIS DUEL COLLECTION CHEST DRAIN
• Type of Device: OASIS DRY SUCTION WATER SEAL CHEST 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: 5309213
• MDR Text Key: 33833644
• Report Number: 1219977-2015-00347
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/04/2018
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 228101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2015
• 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