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

Model Number US5300

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded in (b)(6).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: 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 harm to the patient.

• Brand Name: RATE-FLOW
• Type of Device: INTRAVASCULAR 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 Key: 7969263
• MDR Text Key: 123837803
• Report Number: 9611707-2018-00041
• Device Sequence Number: 1
• Product Code: LDR
• UDI-Device Identifier: 08436020767234
• UDI-Public: 08436020767234
• Combination Product (y/n): N
• PMA/PMN Number: K851058
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: US5300
• Device Catalogue Number: L2590260-US5300
• Device Lot Number: 180946L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1