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

Lot Number UNKNOWN

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Nausea (1970); Hot Flashes/Flushes (2153)

Event Type  Injury  

Event Description

Spoke to patient¿s mother due to recall cadd legacy cassettes.Patient using cassette for iv remodulin infusion/ self mix.Mother did not have access to cassettes on hand, but stated patient had symptoms of nausea, flushing and shortness of breath on a couple of occasions.Currently patient is asymptomatic.When mother gets home she will go through cassettes, pull affected lot numbers and call pharmacy back.No further information.Did the reported product fault occur while in use with a patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the cassette available to be returned for investigation? yes.What is the outcome of the event? resolved.Describe in detail any and all damage to the cassette: n/a.Has this incident happened within the past 6 months? yes.No further info.Iv remodulin pt.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? no, is the actual product available for investigation? yes, did we replace the cassette? mother unsure if she bad lots in hand; did the patient have additional cassettes they were able to switch to? didn¿t switch, currently no issue, 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? yes, what is the outcome of the event? resolved, resolved? ongoing? reported to cvs/caremark by: patient/caregiver.

• Brand Name: CADD LEGACY CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 16003866
• MDR Text Key: 305846240
• Report Number: MW5113846
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Sex: Female