MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY

Model Number 6400

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/23/2017

Event Type  malfunction  

Event Description

Patient reported one of his pumps (did not have sn at the time - will call pharmacy back to provide) keeps alarming with no error message.Patient reports other pump working fine.Advised to be safe we will send patient replacement pump.Patient reported no issues.Patient will be sent return box.No other information available.Dose or amount: veletri 14.75 nkm.Frequency: continuous.Route: iv.Dates of use: (b)(6)2016 to present.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6834348
• MDR Text Key: 84342945
• Report Number: MW5071874
• 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: 08/23/2017

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
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR