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

Lot Number 939660

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

Iv premix patient- per pt, 1 mix from emergency kit used.Patient service representative set up delivery of replacement emergency-kit.Pt reports he changed batteries, extension line, switched to different pump, internal bladder was slightly out of cassette, bubbles in the line.Pt used emergency-kit and drew up mediation himself after experiencing these issues with the cassette.Unknown if pt got an alarm/error message.Pt confirms no issues with using emergency-kit therapy was not interrupted due to cassette issues.Lot number provided: 939660 for cassette per sprx.No add'l info, details or dates are available at this time.Return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow and volume aer unk.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.
• MDR Report Key: 15616260
• MDR Text Key: 301980751
• Report Number: MW5112661
• 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: 09/07/2022

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
• Device Expiration Date: 10/31/2023
• Device Lot Number: 939660
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2022
• Patient Sequence Number: 1
• Patient Sex: Male