MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE 100ML W/ FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 174920

Device Problem Gas/Air Leak (2946)

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

Event Date 03/30/2020

Event Type  malfunction  

Event Description

Ae & pc outbound.Reports having six cassettes that had air leaks in the tubing on top of cassette or at the connection of tubing to inner medication reservoir.She had a lot of champagne sized bubbles in the tubing and reports that on (b)(6) she had chest pain when this occurred.Affected cassettes are 174920 cadd cassette 100 ml with flowstop.Lot 3882469.23-sep-2024 x 6.No further details provided chest pain.

• Brand Name: CADD CASSETTE 100ML W/ FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 9967265
• MDR Text Key: 188281866
• Report Number: MW5094151
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/30/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 174920
• Device Lot Number: 3882469
• 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: 67 YR