MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/01/2016

Event Type  Injury  

Event Description

Patient called in to report her cadd legacy pump was alarming.No messages were displayed on the pump.Tried to trouble shoot to no avail.Replacing pump for tomorrow (bos that we send new pump in is also the return box) serial number (b)(4).Patient was infusing at time of event but there were no side effects noted.Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL ; minneapolis MN
• MDR Report Key: 6089449
• MDR Text Key: 59579420
• Report Number: MW5065910
• 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: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR