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

Model Number	3620-100
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that during the postoperative period of the patient the oasis drain was observed to have bubbling and presence of blood in the water seal chamber.No patient injuries reported.
Additional Manufacturer Narrative
The details of this complaint "identified bubbling and presence of blood in the vacuum chamber in the reservoir of the oasis atrium drainage system in the postoperative period of the rsbb patient on (b)(6) 2022, requiring the replacement of the entire set.No injuries to the patient." this was identified during the treatment of the patient.The video provided of the drain in use confirms the reported event, however, the drain appears to be working as expected.Upon review of the video, it would appear as if the chest drain was knocked over at some point during use or was allowed to over flow.Within the attached video the stand of the drain is not properly set to stabilize the drain.It is not in the locked position.Other evidence is that there is blood on the float ball at the top of the drain showing that blood had come in from the top of the drain in column "b" as seen in the attached image.If the drain were knocked over this is where the blood would enter down into the water seal/air leak monitor area "c".If the drain were to overflow this is also the path the blood would take as well.A review of dhr 471064 was performed and all devices in lot: 471064 passed all quality requirements.No non-conformities were identified in the manufacturing process.The investigation has determined that the most likely root cause of the reported event is that the drain was knocked over during use ¿ operational context h3 other text: not available for return.
Event or Problem Description
N/a.

• Brand Name: DRAINS OASIS DOUBLE
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 14089891
• Report Number: 3011175548-2022-00123
• Device Sequence Number: 5791821
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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 Expiration Date: 05/14/2024
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 471064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 08/08/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/20/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown