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

Model Number N/A

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient advised that 10 days ago and 3 days ago he received high pressure alarm after changing his cassette, he switched pumps and had same error message, he made a new cassette and changed tubing and advised the pump ran fine.The lot number for cassette, is 4434153.He said the top of the cassette tubing seemed a bit more raised than usual.No further information.No additional information, details or dates available.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.Did the reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided?.Is the actual cassette available for investigation? no.Did we replace the cassette? yes.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.If no, what was the patient instructed to do in able to continue their infusion?.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Resolved? yes, ongoing? reported to (b)(6) by: (b)(6).Reference report: mw5117170.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16853313
• MDR Text Key: 314496889
• Report Number: MW5117171
• 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: 04/26/2023

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 Model Number: N/A
• Device Lot Number: 4434153
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Patient Sequence Number: 1
• Patient Sex: Male