MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number	3620-100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
Customer has complained that tubing is kinked since packaging has been changed.Patients are being transferred from theatre to intensive care unit (icu) and drains are kinking.
Additional Manufacturer Narrative
Analysis: the oasis chest drains in question were evaluated to determine the cause of the complaint.Upon review of the returned tube sets there was one kink in the same location on every tubing set evaluated.To determine if the kink in the tubing prohibited flow each tubing set was tested per test procedure.The test procedure was created and derived based on the requirements set forth in iso standard bs en iso 10079-3 2014.The results of this testing indicate that even with the kink in the tubing the airflow met the procedural requirements of 7.5 slpm.The lowest value seen was 27.5 slpm.This far exceeds the procedural requirement.To date there have been no other complaints from around the world.Except from the two institutions in australia.There have been over (b)(4) produced since this change was implemented in february of 2019.Summary/conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the patient tube set kinking creates a patient risk.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8809280
• Report Number: 3011175548-2019-00782
• Device Sequence Number: 19417468
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention