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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/09/2017

Event Type  malfunction  

Event Description

Pt's pump keep alarming high pressure while in use by the pt.She has trouble shooted them multiple times and was also hospitalized for this issue and they found it is nothing internal.Pt and doctor's office want both pumps replaced.We are replaced both as requested.No further info is known.No adverse events occurred.Dose or amount: 70ng/kg/min, frequency: continuous, route: iv.Dates of use: (b)(6) 2015 to current.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY PUMP
• Type of Device: INFUSION, PUMP
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6806781
• MDR Text Key: 83227639
• Report Number: MW5071696
• 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: 08/09/2017
• 2 Devices were Involved in the Event: 1 2

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: 08/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR