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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER, RI-2; WARMER, THERMAL, INFUSION FLUID
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BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER, RI-2; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Device Problems Fire (1245); Electrical Power Problem (2925)
Patient Problem Insufficient Information (4580)
Event Date 04/03/2021
Event Type  malfunction  
Event Description
A belmont rapid infuser ri-2 was set up for an or trauma case and the clinical staff noticed flames coming from the back of the device.It was put out with an extinguisher, the fire department called, and the device sequestered.Initial assessment points to the device power plug being the source of failure.Contributing factors may include liquid around the power cord or a loose power connection.Dph has requested that all belmont rapid infusers ri-2 devices be pulled from use until the vendor determines the root cause and clears them for use.Manufacturer response for iv infusion pump, rapid infusor (per site reporter): vendor has been notified and is investigating for root cause.They are suggesting removing all ri-2 devices and replace the fleet with an alternative.
 
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Brand Name
RAPID INFUSER, RI-2
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston rd
billerica MA 01821
MDR Report Key11628505
MDR Text Key244229308
Report Number11628505
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2021,04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/06/2021
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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