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

Lot Number 4334153

Device Problems Defective Device (2588); Activation Failure (3270)

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

Event Type  malfunction  

Event Description

Patient reported she had a faulty cassette last night.Lot 4334153.Patient had to make a new mix.No side effects or injuries.Patient stated pump kept beeping until she made a new mix.Reviewed with patient that she has an order ship to arrive tomorrow.Advised patient to call pharmacy back if that happened again.Patient understood no other question or concerns.Photographs were not provided, this is a continuous infusion, set flow rate and volume delivered are unknown, the position of the pump when alarm occurred is unknown.No additional information is available at this time.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? yes.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? new mix.Resolved? yes.Ongoing? no.Reported to (b)(6) 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: 17031713
• MDR Text Key: 316324942
• Report Number: MW5117998
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 05/17/2023

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: 4334153
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2023
• Patient Sequence Number: 1
• Treatment: VELETRI.
• Patient Sex: Female