MAUDE Adverse Event Report: IV LINE; SET, I.V. FLUID TRANSFER

Patient Problems Dyspnea (1816); Headache (1880); Dizziness (2194); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Spontaneous.Pt reports they were hospitalized for 8 days and discharged a couple of weeks ago; admittance and discharge dates unknown.Pt reports they were hospitalized because their port clotted and their iv line was undone, so they had to be restarted on iv treprostinil.Pt reports no current issues with their iv line.Pt reports that initially they had headache when increasing to their current pump rate, but that has subsided.Pt also reports shortness of breath when walking room to room and lightheadedness when bending over.Md is aware.No further information, details or dates available.Reported to (b)(6) by pt/caregiver.Ref report: mw5154330.

• Brand Name: IV LINE
• Type of Device: SET, I.V. FLUID TRANSFER
• MDR Report Key: 19192321
• MDR Text Key: 341265695
• Report Number: MW5154331
• 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: 04/18/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN 10 MG, MFR: CIPLA USA. ; TREPROSTINIL MDV
• Patient Outcome(s): Hospitalization
• Patient Sex: Female