MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE 100ML W/FLOWSTOP; SET, I.V. FLUID TRANSFER

Device Problem Protective Measures Problem (3015)

Patient Problem Malaise (2359)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Inbound.One of prefilled veletri.Cadd cassettes steady beeping then no disposable pump won't run on both pumps.Changed over to new cassette to resolve alarm.Had another one with this result last week.During last weeks event, she was off medication for 20-30 minutes and did not feel well during that time being off her veletri until she was able to switch to a new cassette.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13736982
• MDR Text Key: 287247630
• Report Number: MW5108090
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/01/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2022
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female