MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY

Model Number 6400

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2017

Event Type  malfunction  

Event Description

Patient reports pump keeps alarming while running.No error messages displayed.Confirmed cassette not low and batteries have been changed.Patient using back up pump.Replacement pump being sent to patient.No other information available.(serial number (b)(4)) dose or amount: 100 ng/kg/min.Frequency: continuous.Route: iv.Dates of use: (b)(6) 2017 to present.Diagnosis or reason for use: (b)(6).

• Brand Name: CADD LEGACY
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6839135
• MDR Text Key: 84642313
• Report Number: MW5071915
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR