MAUDE Adverse Event Report: SMITHS MEDICAL CADD; LEGACY

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

Pt is requesting we replace his pump (sn (b)(4)).He states the display is "blurry." we will send a replacement pump and return box.Pt is ok.No questions or concerns.No missed doses or adverse events noted.Dose or amount: remodulin 21ng/kg/min.Frequency: continuously.Route: iv.Dates of use: from (b)(6) 2016 to present.Diagnosis or reason for use: pah.

• Brand Name: CADD
• Type of Device: LEGACY
• Manufacturer (Section D): SMITHS MEDICAL ; st. paul MN
• MDR Report Key: 6692739
• MDR Text Key: 79577674
• Report Number: MW5070834
• Device Sequence Number: 1
• Product Code: LZH
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1