MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY PUMP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/31/2017

Event Type  malfunction  

Event Description

Patient stated alarm sounded but still displayed run.Switched to second pump and running and working fine.Patient reported no side effects.Legacy pump[ serial number (b)(4).Order set up to have patient return pump to pharmacy.Dose or amount: 25nkg.Frequency: continuous.Route: intravenous.Dates of use: from 2011 to current.Diagnosis or reason for use: pulmonary arterial hypertension.

• Brand Name: CADD LEGACY PUMP
• Type of Device: CADD LEGACY PUMP
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6848293
• MDR Text Key: 85433387
• Report Number: MW5072003
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/10/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR