MAUDE Adverse Event Report: NEXUS MEDICAL, LLC NEXUS TKO®; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N3561
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Manifold leaked and soaked the bed after replacing.Previous manifold did not leak and when replaced this next manifold did not leak.

• Brand Name: NEXUS TKO®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 7243797
• Report Number: 7243797
• Device Sequence Number: 13699052
• Product Code: FPA
• UDI-Device Identifier: 10815879020731
• UDI-Public: (01)10815879020731
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2018
• Report Date (Section F): 01/25/2018

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
• Operator of Device: No Information
• Device Model Number: N3561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/25/2018