MAUDE Adverse Event Report: SMITHS MEDICAL CADD-LEGACY 1

Model Number 6400

Device Problems High Readings (2459); Device Displays Incorrect Message (2591)

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

Event Date 12/26/2016

Event Type  malfunction  

Event Description

Pt received error code 1720 on her pump.Yesterday when she went to change her cassette pump reported 7ml left in cassette but nothing was in there.She switched to back up pump and has been infusing with no problem.No injury reported.Malfunctioning pump sn (b)(4).Malfunctioning pump will be returned for investigation and new pump will be sent to pt.No other info provided.Dose or amount: 44ng/kg/min, frequency: continuous, route: iv.Dates of use: (b)(6) 2016 to current.Diagnosis or reason for use: i27.0.

• Brand Name: CADD-LEGACY 1
• Type of Device: CADD-LEGACY
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6215314
• MDR Text Key: 63718647
• Report Number: MW5066979
• 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: 12/27/2016

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
• 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: 12/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR