MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY 6400 PUMP

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2016

Event Type  malfunction  

Event Description

Patient reported cadd legacy pump sn (b)(4) maintenance date (b)(6) 2017 will not turn on.Patient replaced batteries but still will not turn on.Patient was not using pump when malfunctioned.Patient did not have adverse event.Pump replaced and return box sent for malfunctioning pump.Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: i27.0.

• Brand Name: CADD LEGACY 6400 PUMP
• Type of Device: CADD LEGACY 6400 PUMP
• Manufacturer (Section D): SMITHS MEDICAL ; st. paul MN
• MDR Report Key: 6063715
• MDR Text Key: 58843990
• Report Number: MW5065676
• 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: 10/08/2016

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR