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 Arrhythmia (1721); Pain (1994)

Event Type  Injury  

Event Description

Iv remodulin patient using cadd legacy pump.Spoke with patient regarding cassette recall.Confirmed the lots in her possession as4298336 and 4329614 (affected recall lots).Patient reported palpitations more than normal.Patient stated that she recently moved and her car got hit so there's a lot of stress.Doctor is aware.Pt stated that she has lupus.Patient reported tremendous amount of pain throughout her body.Patient is not sure if it's related to the cassette recall or her lupus.Patient went to rest/slept.Patient advised that future orders with be for a week supply of cassettes until issue is resolved.Did the patient have additional cassettes they were able to switch to? all lots are recalled.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.No other information is known.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 alarm 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? no.Is the actual cassette device available for investigation? yes.Did we replace the cassette? yes.Did the patient have additional cassettes they were able to switch to? no, all lots recalled.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? what is the outcome of the event? ongoing, resolved? ongoing? reported to (b)(6) by: patient/caregiver.(b)(6).

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16016136
• MDR Text Key: 305973701
• Report Number: MW5113862
• 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: 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: 4298336
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Sex: Female