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

Model Number 3600-100

Device Problem Air Leak (1008)

Patient Problem Pneumothorax (2012)

Event Date 12/20/2017

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.

Event Description

It was reported that a patient with bilateral chest tubes and two chest drains was connected to a single suction source.The left bellows was all expanded but the right bellow was only 1/3 expanded.A chest x-ray showed the right lung had a 30% increase in the pneumothorax and the left lung had a 25% increase in the pneumothorax.The right drain was changed out and revealed an immediate air leak when previously there was none.The facility reported that it was later discovered that fluid had collected in the side that should not have had fluid in it.

Manufacturer Narrative

The returned unit was received and visually inspected.The front of the drain had been marked with a pen at the 100ml fill level mark.There was also blood in the water seal area of the drain.The outside of the drain was also stained by bodily fluids.To determine if the returned drain was operating properly the drain was prepped per the instruction for use and a vacuum of 109cmh2o was applied to the suction nozzle.The drain regulator was still in the pre-set setting of -20cmh2o.The vacuum realized at the end of the patient tube was -20cmh2o.The bellows of the drain was operating properly as well.The regulator of the drain was then adjusted to the -40cm h2o position.The bellows came out to its full limit and the pressure realized at the patient line was -40cm h2o.The drain again showed that it was operating properly.The patient line vacuum pressure was accurate to the regulator setting.It is unknown why the drain did not function based on the complaint details however the drain when tested performed properly.Based on the performance of the drain the root cause of the complaint cannot be determined.There is a possibility that the wall suction was not strong enough to operate two drains at the same time.In addition, because there was blood in the water seal area of the drain and on the outside of the drain, it is possible that the drain had been knocked over while in use.Clinical evaluation: the oasis chest drain system is indicated for use in 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 post-operative collection and reinfusion of autologous blood from the patientâ¿¿s pleural cavity or mediastinal area.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.

• Brand Name: OASIS
• 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: 7163743
• MDR Text Key: 96347138
• Report Number: 3011175548-2018-00022
• Device Sequence Number: 1
• Product Code: CAC
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• 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
• Other Device ID Number: 00650862110012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• 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