MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY; INFUSION PUMP

Model Number 6400

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Event Description

Spoke with pt, according to her, every time she uses the pump she is using right now for her remodulin, the pump would alarm for no reason and then it will stop once the cassette is attached.However, this time the pump alarmed twice while the cassette is attached.She checked if there's any kink or obstruction in fluid path but there's none.Pt is requesting for pump replacement due to pump malfunction.Malfunction pump sn (b)(4) and expiration date 09/19/2018.No other info provided.The device error happened while in use.It has not caused any harm.We are currently working on getting a replacement sent out.Reported to (b)(6) by pt/caregiver.Dates of use: from (b)(6) 2017 - ongoing.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 7002802
• MDR Text Key: 91212547
• Report Number: MW5073136
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Model Number: 6400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1