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

Model Number UNKNOWN

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

Spontaneous communication.Patient reported that she received a bad cassette in her weekly premix shipment, serial number/expiration date unknown.She tried to use the cassette last night (b)(6) 2023 but when she tried to prime it, it wouldn't work and the pump started beeping and gave a high pressure alarm.Patient thought it was a pump issue and switched to her back up pump and again could not prime cassette and got the same alarm.Patient got another cassette out and put it in the pump and was able to continue infusion without problems.Patient confirmed both pumps are working well and that it was just the one cassette that caused the issue.No interruption in treatment and no adverse event due to cassette malfunction.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 and explain? n/a.Is the actual device available for investigation? yes.Patient will be short 1 mix for this week and will need to use her emergency kit.Sending replacement of 1 mix of emergency kit.Patient is comfortable mixing.Patient does have cassette available for return.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered unknown.Position of pump when alarm occurred is unknown.No additional information is available at this time.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16184936
• MDR Text Key: 307662615
• Report Number: MW5114328
• 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: 01/05/2023

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 Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female