MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NEPTUNE 3 ROVER (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0703001000
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/15/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported by the sales rep that during surgery, the neptune 3 rover was connected to the atrium oasis dry suction water seal chest drain.Upon connection, the surgeon requested suction on the neptune be increased, which is not advised per the ifu (see additional mfg narrative for details).It was reported that the patient passed away post-op and that the patient was unhealthy prior to the procedure.There were no alleged malfunctions of the rover during the procedure that caused or contributed to the patient's death.
Additional Manufacturer Narrative
Per neptune 3 waste management system, ifu 0703-001-700 rev-ab: page 8: 4.2 connection safety warnings: inappropriate connection hazard.Do not connect directly to chest tubes.Do not connect to closed wound drains.Do not connect directly to tracheal tubes.Not for use as a suction source for: intermittent suction applications, patient positioner devices, organ stabilizer/positioner devices, death or serious injury can result from inappropriate connections.

• Brand Name: NEPTUNE 3 ROVER (120V)
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20212283
• Report Number: 3015967359-2024-01795
• Device Sequence Number: 12727122
• Product Code: JCX
• UDI-Device Identifier: 07613327116656
• UDI-Public: 07613327116656
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown