MAUDE Adverse Event Report: ATRIUM MEDICAL OASIS DUAL DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Difficult to Open or Close (2921)

Patient Problem Therapeutic Response, Decreased (2271)

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.[(b)(4)].

Event Description

A medwatch user facility report ((b)(4)) was received from the fda.The report received stated that a oasis dual chamber drain was attached to the patient, not realizing the secondary port was not capped and was left open to air.Approximately 10 minutes later the patient began experiencing worsening symptoms of his pre-existing subcutaneous emphysema, in which the medical team elected to proactively intubate the patient.The patient was then transferred to the intensive care unit (icu).

Manufacturer Narrative

As stated in the reported complaint details an oasis dual chamber drain was attached to the patient without the secondary port being clamped off, therefore it was left open to the air.The second patient line if not being used must be clamped as specified in the instructions for use.Based on the information received regarding the details of the event this is not a malfunction of the product, but yet a user error.Clinical evaluation: the oasis chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It is also used to facilitate postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.Subcutaneous emphysema is often seen after thoracic surgical procedures.In most cases it is due to a leak from the lung parenchyma and is self-limiting, requiring no specific treatment.Another cause would be the result of an incorrectly placed chest tube.Massive subcutaneous emphysema, however, should be treated both to reduce discomfort and to prevent respiratory distress and respiratory failure.The instructions for use (ifu) instruct that dual collection models (2 patient tubes) require both patient tubes to remain connected to the patient.When using dual collection models with only one patient tube connection (1 tube only), the patient tube not in use must remain securely clamped off at all times.The ifu also states patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.

Event Description

N/a.

• Brand Name: OASIS DUAL DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8016772
• MDR Text Key: 125385224
• Report Number: 3011175548-2018-01217
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 88 YR