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

Device Problem Nonstandard Device (1420)

Patient Problems Chest Pain (1776); Headache (1880); Gastroesophageal Burn (4475)

Event Type  Injury  

Event Description

Patient reports she has 5 cassettes, lot 4329617, expiration date unknown; all affected by recall.Patient currently using affected cassette (unspecified lot), but not experiencing any symptoms at this time.Patient is due to change cassette at 11:30pm tonight.Earliest available delivery is for (b)(6) 2022, early morning.Advised patient to go to hospital and not use additional affected cassettes.Patient adamant that she is not going to hospital.She reported previously experiencing off and on chest pains/acid reflux and headache over past 2 weeks (unknown if cassette being used at that time was affected by recall or which lot number).Patient believes these symptoms could be caused by cassette, not currently experiencing these symptoms (resolved), exact date of onset/resolution unspecified.Is the actual product available for investigation? unk; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? no; was the pt able to successfully continue their therapy? yes, but with impacted cassette.Informed pt to seek emergency medical care if symptoms return / worsen and please let cvs know if she is going to the hosp so we can update them on dosing if needed.Pharmacist is notifying md.No add'l info at this time.Pump return tracking info is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when alarm occurred is not applicable.No add'l info is available at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? yes.Reported to cvs/caremark by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16042680
• MDR Text Key: 306205617
• Report Number: MW5113944
• 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: 12/16/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOLAN
• Patient Sex: Female