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

Model Number 3600-100

Patient Problem Insufficient Information (4580)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Elderly male with chest pain.Procedure: coronary artery bypass graft x3.The pleurovac leaked all the fluid from the fluid chamber, no obvious signs of cracks of leaks.No known harm to patient, another one used successfully.Manufacturer response for bottle, collection, vacuum, oasis (per site reporter), will obtain.Manufacturer response for bottle, collection, vacuum, oasis (per site reporter), will obtain.

• Brand Name: OASIS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 18091646
• MDR Text Key: 327614841
• Report Number: 18091646
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(17)260907(10)500313
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Lot Number: 500313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 85 KG