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

Model Number 6400

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Description

Spontaneous.Rn (b)(6) from doctor's office reporting that cassette is not lasting the full 48 hours and patient is changing every 46 hours.Per cnss (b)(6), patient is changing cassette when there are 15 milliliters remaining in the cassette.Unknown why patient is changing cassette earlier.Lot number of cassette is unknown.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occured is unknown.No additional information is available at this time.All known info is contained on this form.If any additional information is received it will be provided on a separate report this is a patient use error.No fault with cassette.Pending response from md regarding user error.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 cassette available for investigation? unk; did we [mfr] replace the cassette? no; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? ongoing, pending response from md office.Reported to cvs/caremark by health professional.

• Brand Name: LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 14855403
• MDR Text Key: 295054450
• Report Number: MW5110583
• 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: 06/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female