MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE 100ML W/FLOWSTOP; SET IV FLUID TRASFER

Lot Number 3716369

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

Inbound, cadd cassette causing alarm on both pumps so changing over to new cassette having to waste medication.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET IV FLUID TRASFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 8396252
• MDR Text Key: 138211040
• Report Number: MW5084685
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3716369
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1