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

Device Problems Material Deformation (2976); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2002

Event Type  malfunction  

Event Description

Inbound.Daughter stated cadd legacy pump alarming no disposable with brand new cassette, the top of the cassette was not smooti-l and had a bump in the tubing across the top.She had one cassette last week and a cassette tonight that caused pump alarm.Daughter put on another cassette and the pump worked without alarm, no serial numbers, 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: 13809036
• MDR Text Key: 287553637
• Report Number: MW5108241
• Device Sequence Number: 2
• 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: 02/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 59 YR
• Patient Sex: Female