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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 US5300
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
As reported by user facility: event 2.An "in house" test of the product using a 1 liter bag of fluid and the same gravity tubing that is being used in the community was performed.Customer did follow the directions for set up of the system including height requirements, etc.The flow regulator was set to infuse at 250 ml/hr, which should have infused over 4 hours, but the iv fluid ran through in just under 2 hours.No patient involvement.
 
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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 Key7914864
MDR Text Key122007428
Report Number2532083-2018-00018
Device Sequence Number1
Product Code LDR
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/10/2021
Device Catalogue NumberUS5300
Device Lot Number180946L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Distributor Facility Aware Date09/07/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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