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

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Inbound.Patient reports no disposable alarm on legacy 6400 pump.Despite troubleshooting, alarm persists, cassette changed and alarm resolved, lot number and expiration date of cassette are not available.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: 13757838
• MDR Text Key: 287264555
• Report Number: MW5108124
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female