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

Model Number	3612-100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received from fda¿s medwatch program (mw5103675).Report stated that a chest tube was placed to dry suction and briefly after, the infant appeared dusky with severe oxygen desaturation and continued low map from umbilical artery catheter (uac) and blood pressure (bp) cuff, concerning for continued hypotensive shock.The pleurovac used appeared to be malfunctioning, which possibly contributed to her acute decompensation following chest tube (ct) placement.It was then removed and the existing ct was used to aspirate 180 ml of free air until a functioning pleurovac was attached and set to 30 mmhg.
Additional Manufacturer Narrative
This complaint was received through the fda's medwatch program and the identity of the complainant is unknown.The medwatch report explains that an oasis pediatric chest drain (p/n 3612-100) was set up on an infant who then experienced oxygen desaturation and low mean arterial pressure.The drain was then removed, 180 ml of air was aspirated through the chest tube, and another drain was set up.No pictures were provided and the drain was not returned for evaluation.Because the identity of the complainant is not known, they could not be contacted to request additional information.A medical assessment (attached) was completed with the limited information available.The medical assessment considers that the medical history, surgery details, pre-existing conditions, comorbidities, and post-operative treatment of the patient is unknown and not enough information was provided to determine whether or not the device was properly set up.It concludes that the patient's condition was likely multifactorial and it is likely the drain was not the only contributing factor to the reported patient conditions.The dhr was reviewed and found no nonconformities or anomalies in its manufacturing.No non-conformance reports (ncrs) have been opened involving the lot of this device.The ifu provides adequate instructions for setup and use of the device.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.The limited information and anonymous nature of the complaint make it impossible to confirm the event occurred or that any device nonconformity occurred.A review of complaint trending, complaint history, and capa history did not reveal any systemic issues with the device that may have contributed to this complaint.The root-cause is impossible to define.H3 other text: device not available for return.
Event or Problem Description
N/a.

• Brand Name: DRAINS OASIS PEDI
• 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: 12575711
• Report Number: 3011175548-2021-01018
• Device Sequence Number: 16957882
• Product Code: KDQ
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 04/16/2024
• Device Model Number: 3612-100
• Device Catalogue Number: 3612-100
• Device Lot Number: 470145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female