MAUDE Adverse Event Report: STRYKER INSTRUMENTS NEPTUNE 3 WASTE MANAGEMENT SYSTEM AND PLEUR-EVAC; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient underwent a left upper lobectomy.At the end of the procedure, the patient had a chest tube in place which was connected directly to a fluid suction device (neptune) for a short period of time.During this time, the fluid suction device (neptune) was turned up to a medium/high flow rate.The direct suction connection (neptune) was realized and disconnected.The chest tube was then connected to a closed drainage system (oasis pleur-evac) which was then reconnected to wall suction.Before closing, the patient was assessed and determined to have an air leak in the left lung.The air leak was sealed and the patient was closed.The injury was considered mild and the patient was monitored closely with no adverse effects.Fda safety report id# (b)(4).

• Brand Name: NEPTUNE 3 WASTE MANAGEMENT SYSTEM AND PLEUR-EVAC
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 15300680
• MDR Text Key: 298832920
• Report Number: MW5111721
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White