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

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Dizziness (2194); Pallor (2468)

Event Type  Injury  

Event Description

Spontaneous.Pt's spouse and pt report that pump [serial number unavailable - spouse at work and patient has vision issues following a covid-19 infection in (b)(6) 2021] ran out of veletri sooner than expected.Pump showed that it still had volume remaining but med ran out and pump did not alarm.Pt was without veletri for a short period of time until spouse could get home from work and change cassette.Pt was pale and lightheaded.They were unable to switch to alternate device because shipment was pending arrival.Pt was able to resume infusion with pump in question.Pump is being replaced out of precaution.No other information, details or dates 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 the pump when alarm occurred is unk.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? not required; is the actual product available for investigation? yes; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? no; was able to get pump in question working was the pt able to successfully continue their therapy? yes; reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14623777
• MDR Text Key: 293571643
• Report Number: MW5110152
• 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: 06/03/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/06/2022
• Patient Sequence Number: 1
• Patient Sex: Male