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

Model Number	3612-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that a leak was detected prior to using the drain on a patient.No patient involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: the oasis drain was removed from the packaging and inspected for any damage.No damage was found.Upon initial inspection there was fluid in the water seal chamber and in the collection chamber of the drain.The details indicate that the drain was leaking.It is not clear based on the details where the device was leaking.The additional information received about the leak was described as follows: "the leak was discovered when the customer was filling the water seal with the pre-filled ampule¿.To determine if the drain was leaking the drain was filled to the 2cm fill line on the water seal chamber through the suction port.The drain did not leak when the water was added to the drain.The drain was allowed to rest for a full hour and the drain still showed no signs of a leak.Additional fluid was added through the syringe port/grommet in the back of the drain.Again there were no signs of leakage.Every drain that is produced is 100% pressure tested in manufacturing to ensure there are no leaks.Conclusion: based on the results of the investigation we cannot confirm that the oasis chest drain had a leak.

• Brand Name: OASIS PEDI DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8696897
• Report Number: 3011175548-2019-00664
• Device Sequence Number: 11173667
• Product Code: CAC
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3612-100
• Device Catalogue Number: 3612-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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