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

Lot Number 4334053

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Patient reports cassettes that were defective; no details provided.Patient reports 3 defect cassettes from lot number 4329619 and 1 defective cassette from lot number 4334053.Patient reports they were able to continue veletri infusion by using their back-up pump with a new cassette.No additional info, details, or dates available.Pump return tracking information is not available as no pump issue was reported.Photographs were not provided.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when alarm occurred is unknown as no pump issue was reported.Reported to (b)(6) by: patient/caregiver.Reference reports: mw5116662, mw5116663, mw5116664.

• 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: 16751397
• MDR Text Key: 313534293
• Report Number: MW5116665
• 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: 04/05/2023

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
• Device Lot Number: 4334053
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2023
• Patient Sequence Number: 1
• Patient Sex: Female