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

Model Number 6400

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

Pharmacy reached out to patient to see if she has malfunction with cassette/pump based on md office request patient stated that she is not sure what happened with her pump.She is not sure if it's the battery or what exactly.Her pump is currently working with no issues.She didn't report any interruption in treatment.No side effect reported.Patient went to hospital to figure out what was wrong with cassette and or pump and patient received new cassette at the hospital.Patient was not admitted rn reported that hospital noted that patient had faulty cassettes but patient stated her lot numbers are not affected.No other information provided.Patient didn't have the lot number of cassette used during event to report pump serial number (b)(4) and (b)(4) due for maintenance on august, 2023.Unspecified which pump was in use at time of event.No replacement for pump or cassettes needed at this time.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual product available for investigation? no.Did we [mfr] replace the product? no.Did the pt have a backup product they were able to switch to? no.Was the pt able to successfully continue their therapy? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16132377
• MDR Text Key: 307096002
• Report Number: MW5114252
• Device Sequence Number: 2
• 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: 01/04/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/01/2023
• 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 Sex: Female