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

Lot Number 4235243

Device Problems Display or Visual Feedback Problem (1184); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous patient to report faulty cassettes.Patient states that 2 different cassettes were giving error messages because the tubing inside is crimped inside.Both cassettes have the same lat number for both 4235243.Patient is holding on to one cassette and already threw out the other cassette.No additional information, details or dates are available at this time.Return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? one cassette is available; did we replace the cassette? yes, did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.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: 15419719
• MDR Text Key: 300067821
• Report Number: MW5112039
• 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: 09/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4235243
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Patient Sequence Number: 1
• Patient Sex: Male