MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 11/07/2019

Event Type  malfunction  

Event Description

The bag contained lasix 500mg in 50 ml of fluid and the dose to infuse is 20mg/hr or 2 ml/hr.Two rn confirmed correct pump settings during handoff and they discussed that the bag had recently been changed.At 11am the pump alarmed infusion complete.At that time the nurse noted that the entire bag of lasix had infused.The pump and tubing was sequestered.Pump interrogated by hospital.Tubing available for company evaluation.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 9805293
• MDR Text Key: 182544520
• Report Number: 9805293
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1