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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970)

Event Type  Injury  

Event Description

Spoke to pt regarding cassette recall.Pt is using lot number 4321040 and has 2 cassettes on hand.Pt.Was advised on call yesterday that 4321040 is not the affected lot but pt now informed that the cassette on hand are in fact from the affected recall lot.Pt advised to quarantine the cassettes from affected lots until return is scheduled.Pt will prepare a mix today using new cassettes received.Pt stated that they are doing fine.Pt states that they feel side effects when they do the cassette changes - seems like pt gets a bolus of med and will experience headache and nausea.Pt states it happens most of the time when changing the cassettes.Right now pt feels like they are sometimes getting more of the infusion.Unknown if md aware.Iv remodulin pt.No additional info, details, or dates available.Pump return tracking information¿s not available.Photographs were not provided.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when an arm 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? yes.If yes, was any medical intervention provided? none.Is the cassette device available for investigation? yes.Did we replace the product? yes.Did the patient have a backup product they were able to switch to? yes.Was the patient able to successfully continue their infusion.Yes.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: 16016053
• MDR Text Key: 305980972
• Report Number: MW5113860
• 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: 12/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Sex: Male