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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 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
The belmont rapid infuser, ri-2 has been returned to belmont for investigation; evaluation of the unit is in process.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 follow-up report will be submitted upon completion of the investigation.
 
Event Description
The user facility reported that the rapid infuser, ri-2 was tripping the internal circuit breaker and the ac outlets in the room.
 
Manufacturer Narrative
The belmont rapid infuser, ri-2 was returned to belmont for investigation.Upon receipt, it was identified that several transistors and two optocouplers on driver a/b boards were shorted and damaged.This caused the internal system circuit breaker to trip as reported, however belmont was unable to confirm the report that the system tripped the ac outlets in the room.Root cause of the damaged components could not be established.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.Ensure that circuit breaker is easily accessible to turn off in an emergency situation." the manufacturing records for this serial number were reviewed and no anomalies were identified.No patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.
 
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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
Manufacturer (Section G)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA 01821
Manufacturer Contact
sabrina belladue
780 boston road
billerica, MA 01821
9783307637
MDR Report Key12257345
MDR Text Key264472163
Report Number1219702-2021-00103
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10896128002760
UDI-Public(01)10896128002760
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/01/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received08/01/2021
Supplement Dates Manufacturer Received07/02/2021
Supplement Dates FDA Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
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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