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

Model Number	N3561
Health Effect - Clinical Code	Low Pulmonary Arterial Wedge Pressure (2479)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Iv manifold broke while disconnecting manifold from port tubing to draw blood cultures.The round portion of the manifold that screws into the ports tubing popped off of the rest of the manifold, making it impossible to hook the manifold back up to the port tubing.In order to replace the manifold, the new manifold had to be flushed with saline.Thus it took a while for the drips that had been infusing in the manifold (fentanyl, versed, and epinephrine) to reach the patient.Resident and charge rn were notified of resulting decrease in mean arterial pressures (maps) due to delay in epinephrine reaching the patient.Pt remained stable, maps returned to within defined limits after ~15 minutes of infusion through the new manifold.Damaged manifold put in plastic baggie and left in supervisor's mailbox for viewing.

• 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: 7243767
• Report Number: 7243767
• Device Sequence Number: 984153
• 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: Nurse
• Device Model Number: N3561
• Was Device Available for Evaluation?: Yes
• 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