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

Lot Number 4103163

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Inbound.Spouse reported patient had no disposable pump wont run alarm on cadd legacy pump with cadd flow stop cassette lot 4103163 just after veletri cassette change.Alarm resolved by changing to another veletri cassette.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: 12057484
• MDR Text Key: 258379813
• Report Number: MW5102076
• Device Sequence Number: 1
• Product Code: LHI
• 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: 06/02/2021

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: 4103163
• 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: 77 YR