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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Arthralgia (2355)

Event Type  Injury  

Event Description

Treprostinil: pt reported the following side effects: headache and joint pain that she usually gets with dose increases, which always have gone away after a few days or so.No additional information provided.Pt noted that she has had issues with 2 cassettes (lot number unknown) since last fill.Both times, her pump was starting to beep and give error messages (pt forgets what the message read) when the cassette volume was around 30 ml.Both times, pt was due to change cassette that day so she replaced her cassette which solved the issue.She does still have the cassettes in question.Rph advised pt to keep them aside from her supply in case manufacturer would like them to be returned for investigation.Author advised pt that she can try pushing the bladder back into the cassette where the blue tab was removed and see if that resolves any issues.No problems with pumps, nothing needs replaced.No additional information known.Photographs were not provided.Set flow rate and volume delivered are unk.Position of the pump when alarmed occurred is unk.This is a continuous infusion, all known info is contained on this form.If any add'l info is received, it will be provided on a separated report.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? no; is the actual cassette available for investigation? yes; did we replace the cassette? no; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6)/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: 14488416
• MDR Text Key: 292596373
• Report Number: MW5109860
• Device Sequence Number: 2
• 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: 05/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female