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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

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BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER Back to Search Results
Model Number RI-2
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
The belmont rapid infuser, ri-2 involved in the incident has not been returned to belmont for investigation.This report is for serial number (b)(4); a separate report will be entered for serial number (b)(4).There is insufficient information available at this time to establish a root cause of the reported circuit breaker tripping.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adapter for ungrounded outlets." the manufacturing records for this serial number were reviewed and no anomalies were identified.No patient injury was reported.A supplemental report will be submitted as more information becomes available.
 
Event Description
The hospital biomed relayed the following report from the physician involving a rapid infuser, ri-2: "today in one of our cardiac rooms, we were infusing just normal saline at a rate of reported 2.5ml/min.While in use the belmont tripped the wall breaker, and tripped the internal breaker in the device itself.After several attempts of swapping power supply sources and trying to turn the device back on, both breakers continued to snap off.When i turned the device on without plugging the belmont into a wall power supply, the unit would stay on and not flip its internal breaker." the reported incident involved two ri-2 units.This report is for serial number (b)(4); a separate report will be entered for serial number (b)(4).
 
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Brand Name
THE BELMONT RAPID INFUSER
Type of Device
THERMAL INFUSION FLUID WARMER
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA 01821
MDR Report Key12290955
MDR Text Key265586966
Report Number1219702-2021-00106
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10896128002760
UDI-Public(01)10896128002760
Combination Product (y/n)N
PMA/PMN Number
K141654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRI-2
Device Catalogue Number903-00039
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/07/2021
Initial Date FDA Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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