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

Model Number 6400

Device Problem Infusion or Flow Problem (2964)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

Spontaneous: pt's husband reports that the pump recently sent has malfunctioned (serial (b)(4) [maintenance due 11/14/23)).Pump started beeping to change out cassette but he stated there was at least another 11 hours left in the cassette as they change at 07:30 every morning.Asked if he was aware of the cassette lot number and he mentioned that he got a call about them and were replaced recently and doesn't believe it is a cassette issue.Patient has since transitioned to backup pump and is doing fine.Did mention that he found his wife passed out on the floor but doesn't believe it was for a significant amount of time.Unknown if related to pump.Claims patient is doing fine at the moment.No further information provided.Report is for pump only.Product lot number and expiration date were systematically retrieved from the dispensing system.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? pt passed out; unk if related to pump malfunction.If yes, was any medical intervention provided? unk.Is the actual product available for investigation? yes.Did we [mfr] replace the product? yes.Did the pt have a backup product they were able to switch to? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: PUMP CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16094721
• MDR Text Key: 306720950
• Report Number: MW5114147
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/14/2023
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: VELETRI
• Patient Sex: Female