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

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

Remodulin iv premix pt - pt reported problem with one of her cassettes.She was trying to change her cassette and had error cassette empty.She tried other pump and same error; she disposed this cassette and use different with no problems.The reported product fault did not occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The cassette is not available to be returned for investigation.The event is resolved.Lot number not provided.No additional info, details, or dates available.Return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.Reported to (b)(6) 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: 16832663
• MDR Text Key: 314269769
• Report Number: MW5117093
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Patient Sequence Number: 1
• Patient Sex: Female