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

Lot Number 4189939

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

Inbound.Spouse reported no disposable clamp tubing alarm on both cadd legacy pumps about 10 hours after cassette change.Caller also had difficulty filling cassette this am due to hard to push enough air in cassette to remove the small air bubbles.Cassette lot 4189939, expiration 08/30/2026.Cassette wasted due to alarm unresolved, no further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13809683
• MDR Text Key: 287575751
• Report Number: MW5108264
• Device Sequence Number: 1
• 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
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4189939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2022
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female