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

Model Number	US5300
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon s.A.U.As a customer complaint (reference (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 or Problem Description
As reported by user facility: event 1.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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 7969283
• Report Number: 9611707-2018-00047
• Device Sequence Number: 19146126
• Product Code: LDR
• UDI-Device Identifier: 08436020767234
• UDI-Public: 08436020767234
• Combination Product (Y/N): N
• PMA/510(K) Number: K851058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: US5300
• Device Catalogue Number: L2590260-US5300
• Device Lot Number: 161332L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1