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

Lot Number 4096351

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

Inbound.Remodulin patient reports cassette that seems to trigger no disposable alarm.Lot 4096351, exp 01/29/2026.No further details provided.Internal pc-cassette issue, no disposable alarm.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11893369
• MDR Text Key: 253209207
• Report Number: MW5101581
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 49 YR