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

Device Problems Infusion or Flow Problem (2964); Noise, Audible (3273)

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

Event Type  Injury  

Event Description

Spontaneous communication from patient.Patient reports she has 16 cassettes with lot 4321040, expiration date unknown.Patient is not experiencing any adverse events at this time.Patient has had issues with her cassettes and the pump giving a weird noise.Patient had to go to hospital because of pump issues previously (exact dates of event not provided, length of stay not provided).It is unable to be determined if cassette issue or pump issue, unknown cassette lot number and pump serial number/expiration date at the time event occurred.Unknown if patient was hospitalized due to event or if was only seen in er.Unknown if patient was using impacted recalled lot at time pump issue was experienced.No further information available.Product lot number and expiration date were systematically retrieved from the dispensing system.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when event 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? yes; if yes, was any medical intervention provided? pt went to hospital; is the actual product available for investigation? unk; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? pt using impacted cassette until new order is received.Reported to cvs/caremark by pt/caregiver.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16042634
• MDR Text Key: 306238744
• Report Number: MW5113940
• Device Sequence Number: 8
• 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: 12/16/2022
• 17 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELETRI
• Patient Sex: Female