MAUDE Adverse Event Report: IV PUMP SOLARIS; PUMP, INFUSION

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

Patient Problem Extravasation (1842)

Event Date 11/21/2020

Event Type  Injury  

Event Description

Remdesivir under emergency use authorization (eua): extravasation -> golf ball size amount of fluid.Treated with warm compress.Fda safety report # (b)(4).

• Brand Name: IV PUMP SOLARIS
• Type of Device: PUMP, INFUSION
• MDR Report Key: 10903787
• MDR Text Key: 218552887
• Report Number: MW5098103
• Device Sequence Number: 1
• Product Code: FRN
• 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: 11/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 87