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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVENTON S.A.U. RATE-FLOW INTRAVASCULAR ADMINISTRATION SET

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LEVENTON S.A.U. RATE-FLOW INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number US5300
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded in leventon s. A. U. As a customer complaint (b)(4). The defective unit was not returned to the manufacturer, thus the device was not evaluated. Six (6) units from the same manufacturing lot were retrieved from retained samples and successfully passed flow rate stability test and flow rate accuracy test. In addition, the batch record of the affected lot number was reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release. Therefore, the defect reported by the customer could not be reproduced. Anyway, nothing justifies the occurrence of such an incidence. The position of 250 ml/h is the maximum value of the scale of the flow regulator. Then, if the directions for setting up the product according to the ifu are followed, it is not possible to get the double of flowrate in this position.
 
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 NameRATE-FLOW
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
LEVENTON S.A.U.
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP 08635
Manufacturer (Section G)
LEVENTON S.A.U.
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP 08635
Manufacturer Contact
david salvatierra
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP   08635
MDR Report Key7969280
MDR Text Key125458852
Report Number9611707-2018-00040
Device Sequence Number1
Product Code LDR
Combination Product (y/n)N
PMA/PMN Number
K851058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2021
Device Model NumberUS5300
Device Catalogue NumberL2590260-US5300
Device Lot Number180946L
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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