MAUDE Adverse Event Report: IV INFUSION; SET, ADMINISTRATION, INTRAVASCULAR

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 12/23/2021

Event Type  Injury  

Event Description

A (b)(6) m with ankylosing spondylitis on humira, became infected with covid.Poor oral intake while sick.Was given sotrovimab iv once; during infusion developed nausea.During the i-hour post-infusion monitoring, the patient developed hypotension which responded to fluid resuscitation.Discharged to home upon completion and doing well at 7-day follow-up.Symptoms : symptoms: nausea, vomiting, hypotension, treatment drugs used: sodium chloride (sodium chloride 0.9% inj,bag,500ml) dose: 500 units: ml freq: once route: iv.

• Brand Name: IV INFUSION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 13176111
• MDR Text Key: 283441229
• Report Number: MW5106475
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 76 KG