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

Model Number 6400

Device Problems Activation Failure (3270); Priming Problem (4040)

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

Event Type  malfunction  

Event Description

Unsolicited communication: patient called in reporting pump alarm.Alarm read "no disposable pump wont run".Patient tried cassette (lot number: unknown) on back up pump with same issue.Patient mixed new cassette and tried again on back up pump (serial: (b)(4)) but was giving priming issues and same error message.Patient tried cassette again on first pump and infusion was running smoothly.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Event is for one cassette and one pump.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 15536881
• MDR Text Key: 301173230
• Report Number: MW5112385
• Device Sequence Number: 1
• Product Code: LHI
• 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: 09/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/23/2023
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: EXTENSION SET
• Patient Sex: Female