MAUDE Adverse Event Report: LEVENTON, S.A.U. RATE FLOW® CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC

Catalog Number V5922

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 10/15/2018

Event Type  malfunction  

Event Description

As reported by user facility: an infusion that should have taken one hour, took five.

• Brand Name: RATE FLOW®
• Type of Device: CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC
• Manufacturer (Section D): LEVENTON, S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 8025933
• MDR Text Key: 125767090
• Report Number: 2532083-2018-00020
• Device Sequence Number: 1
• Product Code: LDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/06/2021
• Device Catalogue Number: V5922
• Device Lot Number: 180810L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2018
• Distributor Facility Aware Date: 10/15/2018
• Event Location: No Information
• Date Report to Manufacturer: 10/31/2018
• 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