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U.S. Department of Health and Human Services

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

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NEXUS MEDICAL, LLC NEXUS TKO® SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameNEXUS TKO®
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
NEXUS MEDICAL, LLC
11315 strang line road
lenexa KS 66215
MDR Report Key9362318
MDR Text Key167598461
Report Number9362318
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN3561
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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