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

Model Number US5300

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

As reported by the 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®
• 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 Key: 7914869
• MDR Text Key: 122041548
• Report Number: 2532083-2018-00008
• Device Sequence Number: 1
• Product Code: LDR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• 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 Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Distributor Facility Aware Date: 09/07/2018
• Event Location: Home
• Date Report to Manufacturer: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1