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

Model Number UNKNOWN

Device Problems Display or Visual Feedback Problem (1184); Pumping Problem (3016)

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

Event Type  malfunction  

Event Description

Patient reported having to replace 5 cassettes in the past 30 days due to pump alerts.Patient stated two tone alarm but no message on the pump itself.Patient had similar issue earlier in the year.Patient's pumps were replaced in april for same issue.Unknown if reported.This problem has occurred prior to and after receipt of those pumps.Patient can sometimes navigate through the alarm.If she cannot, she prepares a new cassette.Trouble shooting and nursing support offered due to suspected possible user error.Patient did not have product available for return [she disposed of after damaging while trying to correct].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.Position of pump when alarm occurred is unknown.Unknown if malfunction or user error.Cassette lot numbers and expiration dates are unknown.Did the reported product fault occur while in use with the patient? yes, did the product issue cause or contribute to patient or clinical injury? no, if yes, was any medical intervention provided? n/a, 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? n/a, is the infusion life sustaining? yes, what is the outcome of the event? pt switched to new cassettes without any issues., resolved? yes, ongoing? no.Reported to cvs/caremark by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15715623
• MDR Text Key: 303085132
• Report Number: MW5113025
• 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: 10/05/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female