MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES BELMONT RAPID INFUSER - R12; WARMER, THERMAL, INFUSION FLUID

Model Number 903-00039

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  Injury  

Event Description

During a transfusion the rapid infuser provided feedback that there was a high pressure alarm originating in the machine, not at the iv site.The error was recreated after it was no longer connected to a patient.Fda safety report id# (b)(4).

• Brand Name: BELMONT RAPID INFUSER - R12
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; billerica MA 01821
• MDR Report Key: 10250356
• MDR Text Key: 198380156
• Report Number: MW5095440
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR