MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Programming Issue (3014)

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

Event Date 12/06/2016

Event Type  malfunction  

Event Description

Pt reported that she is having issues with the pump we just sent out, sn (b)(4).States that when she changes the battery, the program gets "messed up." a home health rn went out to evaluate the issue and states that the pump is giving an error message (she did not provide details on the error message).Per the rn, she tried all things she knows to resolve the error message, but she is unable to.We are sending out a new pump to replace this pump.No adverse events occurred due to this issue.Dose or amount: 100 ng/kg/min, frequency: continuous, route: iv.Dates of use: (b)(6) 2011 to present.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6185797
• MDR Text Key: 62803501
• Report Number: MW5066770
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2016

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: 12/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR