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

Lot Number 43296147

Device Problems Nonstandard Device (1420); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem Dizziness (2194)

Event Type  Injury  

Event Description

Spontaneous call from patient's wife (b)(6).There was a no disposable error on (b)(6) 2022 and the patient did not hear it so his medication was not infusing for an unknown amount of time and he because dizzy and could not stand until he started his infusion again with a new cassette and increased his oxygen use.Since restarting his infusion he is feeling better.End date of adverse effects is unknown.All cassettes he has on hand are lot 4329614 which is affected by the recall.He will return the cassettes to us and we will ship replacement cassettes.He infuses using the cadd legacy pump.This is a life-sustain infusion.No further information available.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTES
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16026446
• MDR Text Key: 306070189
• Report Number: MW5113906
• 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: 12/14/2022
• 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
• Device Lot Number: 43296147
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Patient Sequence Number: 1
• Treatment: OXYGEN
• Patient Sex: Male