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

Model Number E0100-30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2017

Event Type  malfunction  

Event 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
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6941448
• MDR Text Key: 89381686
• Report Number: 6941448
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00363807100305
• UDI-Public: (01)00363807100305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 09/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 1