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

Lot Number 4096351

Device Problem Device Alarm System (1012)

Patient Problem Lethargy (2560)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

Inbound.Patient reported she called emergency services to her home.The heart monitor had frequent premature ventricular contractions when veletri was not infusing due to a disposable pump alarm on (b)(6) 2021 and that both pumps were alarming.The res volume of cassette was 65 milliliters.After a new cassette was mixed, veletri was restarted in the home and she did not go to the hospital.She started feeling better in 30 minutes.She is feeling tired and weak today from the stress.The lot number of a cassette from the same box was 4096351.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12057233
• MDR Text Key: 258372770
• Report Number: MW5102067
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4096351
• 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: 48 YR