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

Model Number 6400

Device Problem Nonstandard Device (1420)

Patient Problems Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Pt's spouse reports that pt has 4 cassettes on hand from the recall affected lots: 4279821 (1), 4298336(2), and 4284632 (1-currently using to infuse).Spouse reports that the pt changed their cassette on (b)(6) 2022 and all of a sudden last night (b)(6) 2022, pt felt like they were getting too much medication.There were two episodes like that last night (b)(6) 2022.Pt did not change their cassette again so they are still using the same cassette from (b)(6) 2022.No adverse event reported due to cassette issue.Advised spouse to change pt's cassette as soon as possible to one from an unaffected lot and to continue monitoring pt for any symptoms.Pharmacy is replacing recalled cassettes.Pt has also been dealing with a cold and severe cough (onset date unknown) and has a follow-up with md today (b)(6) 2022.Iv remodulin patient.No additional info, details, or dates available.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when event occurred is 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? 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? n/a, is the infusion life-sustaining? yes, what is the outcome of the event? resolved.Resolved? yes, ongoing? n/a.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE LEGACY
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16051424
• MDR Text Key: 306315813
• Report Number: MW5114012
• 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: 12/19/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Device Lot Number: 4279821
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PUMP.; REMODULIN.; TUBING.
• Patient Sex: Female