MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY

Device Problem Device Inoperable (1663)

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

Event Date 09/13/2016

Event Type  Injury  

Event Description

Per pt, this pump is not working.The numbers on the pump are not working.Pt speaks a mixture of spanish/english and it was hard to understand.New pump sent to pt.There was no harm to the pt and no missed dose.Per procedure, the box that the replacement pump is sent in is also the return box.Dose or amount: 47 ng/kg/min.Frequency: continuously, route: iv.Dates of use: from (b)(6) 2014 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 5976337
• MDR Text Key: 55781471
• Report Number: MW5065001
• Device Sequence Number: 1
• Product Code: MEA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR