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

Lot Number 363080

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

Inbound: in the past 2 weeks has had #3 cadd cassette 100ml w/flowstop alarming on both pumps when attempt to use on both pumps.No further details provided.Lot # 363080.

• 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: 8396444
• MDR Text Key: 138095025
• Report Number: MW5084696
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 363080
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1