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 Anxiety (2328)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

Inbound.Patient reported she is in emergency room due to no disposable pump won't run alarm on both pumps with prefilled veletri cassette half full and has been off of med for 30 minutes.Patient reported sweating and feeling anxious.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: 13809649
• MDR Text Key: 287554209
• Report Number: MW5108262
• Device Sequence Number: 1
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female