MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER

Model Number 6400

Device Problem Improper Flow or Infusion (2954)

Patient Problems Hot Flashes/Flushes (2153); Dizziness (2194)

Event Type  Injury  

Event Description

Spontaneous communication.Patient reported that cassette (lot 4329160, expiration date not provided) resulted in a no disposable clamp tubing on both of her pumps (serial numbers (b)(4) expiration dates unknown).Patient disconnected cassette from pump and reconnected it and it wouldn't run and then connected cassette to back up pump and got same error.Patient did not have a cassette already mixed so she had to mill a cassette to replace faulty cassette.Patient experienced hot flashes and dizziness after about 2 minutes of not getting medication due to cassette issue.Patient was able to resume infusion and reported no issues at time of call.Patient did not need replacement cassettes and pumps do not need to be replaced.Product lot number and expiration date were systematically retrieved from the dispensing system.Return tracking info is not available, photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of pump when alarm occurred is unk.No add'l info 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? side effects reported due to pause in infusion.If yes, was any medical intervention provided? no; is the actual product available for investigation? yes; reported to cvs/caremark by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 15825635
• MDR Text Key: 304023221
• Report Number: MW5113351
• 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: 11/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Device Lot Number: 4329160
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female