MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; BOTTLE, COLLECTION, VACUUM

Model Number	3612-100
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Picu rn called for assistance with atrium oasis pediatric drain.Infant had been admitted for pneumothorax and had a chest tube placed.Patient then developed a larger pneumothorax below the first, so a second chest tube was placed after needle aspiration.The caller described that the blue water in the air leak monitor chamber c of the second chest drain had overfilled to water seal chamber b, meaning that there was an acute rise in the water seal chamber level.The drain was changed out and the same thing was observed on the replacement drain.Support team discussed with the caller that this could be indicative of a rise in the patient¿s intrathoracic pressure, and possible clinical reasons.No drainage was observed in collection chamber d.After repeat chest xray it was determined that the patient¿s pneumothorax had increased in size and care team attempted aspiration from the chest tube.Reportedly resistance was encountered during aspiration, but everything returned to normal once the drain was reconnected.
Additional Manufacturer Narrative
Related mdr: 3011175548-2025-0000003.Getinge received a call from a nurse who was aiding in the treatment of an infant with an oasis pediatric drain (p/n 3612-100, l/n unknown).The patient's pneumothorax had increased and the water from the air leak detection chamber had risen up in the water seal chamber.The user was uncertain how to interpret this change and replaced the drain once to ensure it was not a knockover that caused the movement of the water.The second drain (documented in complaint (b)(4)) did the same thing and the user called getinge to inquire what it meant.The getinge representative explained that this is normal behavior of the device and indicates an increase in the patient's intrathoracic pressure.The user was appreciative of the information and had no further questions.No allegations of a device malfunction were made and no additional harm to the patient was reported as a result.A dhr review could not be completed because no lot number was provided.No evidence was identified to suggest that this complaint is related to design, manufacturing, or instructions for use.The ifu provides adequate instructions for setup and use of the device.It explains that the height of the water in the water seal chamber is indicative of the patient pressure, so it should be understood that changes in the height indicate a change in pressure.The ifu contains the information the user called requesting.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 3.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints except for the related complaint (1201185) which was reported at the same time.A recurring lot number report could not be completed because no lot number was provided.This complaint describes normal behavior of the drain and does not allege a device malfunction.The complaint was a request for information on interpreting the drain.The ifu provides the information necessary to prevent this complaint.This complaint is confirmed but a device nonconformance is not.The root-cause of this complaint is user error due to inadequate understanding and interpretation of the drain.
Event or Problem Description
N/a.

• Brand Name: OASIS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• 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: 21110803
• Report Number: 3011175548-2025-000000
• Device Sequence Number: 8719422
• Product Code: KDQ
• UDI-Device Identifier: 00650862111019
• UDI-Public: (01)00650862111019
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3612-100
• Device Catalogue Number: 3612-100
• 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: 12/22/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown