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U.S. Department of Health and Human Services

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

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LEVENTON, S.A.U. RATE FLOW® CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC Back to Search Results
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.
 
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Brand NameRATE FLOW®
Type of DeviceCONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC
Manufacturer (Section D)
LEVENTON, S.A.U.
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP 08635
MDR Report Key8025933
MDR Text Key125767090
Report Number2532083-2018-00020
Device Sequence Number1
Product Code LDR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/06/2021
Device Catalogue NumberV5922
Device Lot Number180810L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/31/2018
Distributor Facility Aware Date10/15/2018
Event Location No Information
Date Report to Manufacturer10/31/2018
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

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