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

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Fatigue (1849)

Event Date 04/10/2022

Event Type  malfunction  

Event Description

Inbound.Daughter stated cadd legacy pump alarming no disposable with remodulin cassette.Stated pump had alarmed earlier this morning and after troubleshooting, the remodulin restarted using same cassette.Using same pump and cassette, remodulin restarted.Serial number (b)(4).Two other cadd legacy pump battery doors would not open.Serial numbers (b)(4) and (b)(4).Pt reports fatigue; not feeling well and scared, 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: 14195056
• MDR Text Key: 290116187
• Report Number: MW5109324
• 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: 04/10/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female