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

Model Number 3600-100

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Overfill (2404)

Patient Problem No Information (3190)

Event Date 06/06/2018

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

Report received stated that an oasis drain became full of fluid and overflowed.

Event Description

N/a.

Manufacturer Narrative

Analysis: based on the details and correspondence with the institution the drain capacity was simply exceeded and not changed out in time to prevent the drain from overflowing.The drains in question are to be monitored to ensure proper function.Being that the patient was losing up to 900ml a day and exceeded 2.0 liters to 2.5 liters almost immediately after being mobile indicates that this patient was certainly a special case where a larger capacity drain or collection device should have been used after being mobile.The device history records were reviewed to ensure all acceptance criteria was met and all performance testing was conducted and met the product requirement.In all instances the chest drains met all criteria and there were no non-conformances related to the complaint noted.Conclusion: based on the complaint investigation results it appears as if the drain capacity was exceeded based on the condition of the patient and the frequency as to which the drain was replaced.There is no evidence that the chest drain was at fault or not working properly.Clinical evaluation: the oasis chest drainage system is indicated to evacuate air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use (ifu) instruct to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and that users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7639333
• MDR Text Key: 112382898
• Report Number: 3011175548-2018-00645
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 426795
• Other Device ID Number: 00650862110012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention