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

Lot Number 4219994

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Anxiety (2328)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Inbound.(b)(6) spouse reports patient discarded four unused and full of mixed treprostinil, 100 ml cadd legacy cassettes with flowstop, lot 4219994.Tried to setup cadd legacy pumps serial numbers (b)(4), but both pumps alarmed no disposable and wouldn't accept cassettes.Cassette and pump replacements sent with box to return.Incapable of troubleshooting the alarms as she gets too upset, very frustrated with ongoing pump and cassette problems, considering stopping therapy due to the anxiety this is causing for nearly a year.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: 14136766
• MDR Text Key: 289524516
• Report Number: MW5109058
• Device Sequence Number: 4
• 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: 03/30/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4219994
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female