MAUDE Adverse Event Report: SMITHS MEDICAL CADD-LEGACY 1; CADD LEGACY

Model Number 6400

Device Problems Device Alarm System (1012); Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913)

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

Event Date 11/26/2016

Event Type  malfunction  

Event Description

Patient reports one of her legacy pumps malfunctioned over the weekend.She advised it was beeping all day (but no error message reported) and the buttons were not working.She advised it was still infusing and she switched to another pump successfully and continued infusing.When she took out the batteries and put them back in the malfunctioning pump, she reported it was going through self testing at high speed.Sn (b)(4).Pump will be returning for investigation.Replacement pump will be sent to patent.Product fault occurred while in use with a patient but patient did not report any clinical injury.No other information provided.Dates of use: (b)(6) 2016 to current.(b)(4).

• Brand Name: CADD-LEGACY 1
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6173265
• MDR Text Key: 62555924
• Report Number: MW5066665
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR