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

Lot Number 4329615

Device Problem Nonstandard Device (1420)

Patient Problems Chest Pain (1776); Headache (1880)

Event Type  Injury  

Event Description

Patient and daughter called in and reported that they have 4 cassettes part of the recall lot: 4329615.Patient reports headache and chest heaviness since this morning.Patient has 2 mixes left and 3 cassettes not part of the recall at this time.Md and nurse are aware.Sending replacement cassettes for tomorrow.No further info.Iv remodulin pt.Product lot number and expiration date were systematically retrieved from the dispensing system.No add'l info, details, or dates available.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.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16026149
• MDR Text Key: 306042819
• Report Number: MW5113897
• 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: 12/15/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329615
• 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: PUMP; REMODULIN
• Patient Sex: Female