MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. EXCELSIOR; SALINE, VASCULAR ACCESS FLUSH

Model Number	E0100-30
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
When used with the carefusion syringe module and microbore tubing, the pump will intermittently alarm and display "occluded patient side." the rn will then flush the line at the hub or through the microbore tubing off of the pump without resistance or increase pressure.Manufacturer response for saline, vascular access flush, excelsior (per site reporter): manufacturer is working with our biomedical department to try and replicate the events.

• Brand Name: EXCELSIOR
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6941448
• Report Number: 6941448
• Device Sequence Number: 13675578
• Product Code: NGT
• UDI-Device Identifier: 00363807100305
• UDI-Public: (01)00363807100305
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/25/2017
• Report Date (Section F): 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 04/01/2019
• Device Model Number: E0100-30
• Device Catalogue Number: E0100-30
• Device Lot Number: 3130571
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 1
• Date Report Sent to FDA: 09/25/2017