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

Lot Number 4321040

Device Problem Protective Measures Problem (3015)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Patient reported she has the following cassettes with impacted lot numbers: 6 cassettes lot: 4321040 affected, 30 cassettes lot: 4282452 affected, a non-affected cassettes on hand.Patient reports symptom of shortness of breath a few times, issues with pump alarming but after switching the pump it was fine so patient never called to report.Cassette lot number that was in use at the time alarm occurred is unknown.Pump serial number/due date was not provided.Patient stated hard to say but her symptoms could be due to cassette issues.Patient will receive replacement cassettes.Pump is not being replaced.Patient was advised to go to the hospital if symptoms or issues persist but she said that was a few days ago.Pharmacy will notify md office.Product lot number and expiration date were systematically retrieved from the dispensing system.Pump return tracking information is not applicable 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.No additional information is available at this time.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? yes.If yes, was any medical intervention provided? - no.Is the actual product available for investigation? ¿ no.Reported to cvs/caremark 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: 16042855
• MDR Text Key: 306246122
• Report Number: MW5113948
• Device Sequence Number: 5
• 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: 12/19/2022
• 36 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUMP.; TUBING.; VELETRI.
• Patient Sex: Female