MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD PUMP; PUMP, INFUSION

Model Number 6400

Device Problem No Flow (2991)

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

Event Date 05/01/2021

Event Type  malfunction  

Event Description

Patient reports pump serial number (b)(4) has been alarming no disposable for the past few weeks.They attempt to realign the cassette but pump will still alarm and they end up needing to mix a new cassette.Author advised we would replace pump but added it could also be a cassette issue.Patient was able to provide lot and expiration date info for current cassette lot 4116349, exp 03/19/2026.Product fault occurred while in use.Product fault did not cause injury.Device available for investigation.Device being replaced.Patient was unable to switch to back up because patient was waiting for backup pump to arrive which also experienced the same issue.Patient able to continue infusion using current pump.Infusion is life sustaining.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12672631
• MDR Text Key: 278083671
• Report Number: MW5104826
• Device Sequence Number: 2
• Product Code: FRN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR