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

Model Number N3561

Device Problems Break (1069); Material Separation (1562)

Patient Problem Missed Dose (2561)

Event Date 10/29/2019

Event Type  malfunction  

Event Description

Iv fluids, versed, fentanyl and vecuronium drips infusing via manifold into patients central line.Plastic end piece of manifold found lying in bed broken into several pieces.Iv fluids and drips infusing into the patient's bed.Subsequently, informed of another manifold that fell apart during use but this one was not saved.

• Brand Name: NEXUS TKO®
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 9362318
• MDR Text Key: 167598461
• Report Number: 9362318
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10815879020731
• UDI-Public: (01)10815879020731
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019

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: No Information
• Device Model Number: N3561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 210 DA