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

Lot Number 3808554

Device Problems Defective Device (2588); Gas/Air Leak (2946); Infusion or Flow Problem (2964)

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

Event Date 07/09/2019

Event Type  malfunction  

Event Description

Patient reported that when pressing and holding the green button on cassette, she is unable to withdraw medication and air bubbles, green button not working, lot# 3808554, exp.2024-04-17.

• Brand Name: CADD CASSETTE 100ML W/FLOWS STOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 8855760
• MDR Text Key: 153388904
• Report Number: MW5088660
• Device Sequence Number: 0
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/17/2014
• Device Lot Number: 3808554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR