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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 Flare or Flash (2942)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2020
Event Type  malfunction  
Manufacturer Narrative
Following receipt of the initial report, belmont's sales representative went to the hospital to investigate the incident.During his visit, he learned that hospital protocol is to have a saline bag hanging (un-spiked) and a tubing set installed with the rapid infuser turned off, but plugged in at all times.When notified of an incoming patient, the saline bag is spiked and the rapid infuser is primed.The remaining two spikes of the tubing set are clamped and left to hang freely.The director of trauma stated that the patient had been taken to get a ct scan and was not connected to the machine at the time of the incident.It was reported that during this time she observed saline from one of the clamped tubing sets leaking onto the power entry.The rapid infuser operator's manual states the following: "we strongly recommend loading and priming the disposable set just prior to the procedure." the unit was returned to belmont for investigation on february 25, 2020.The investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.Upon completion of our investigation, a supplemental report will be provided.
 
Event Description
The user facility reported that the rapid infuser exhibited a spark/flash.It was reported that the unit was plugged into the wall with the saline bag hung above on the iv pole, but was not in use on a patient.
 
Manufacturer Narrative
Following receipt of the initial report, belmont's sales representative went to the hospital to investigate the incident.During his visit, he learned that hospital protocol is to have a saline bag hanging (un-spiked) and a tubing set installed with the rapid infuser turned off, but plugged in at all times.When notified of an incoming patient, the saline bag is spiked and the rapid infuser is primed.The remaining two spikes of the tubing set are clamped and left to hang freely.The director of trauma stated that the patient had been taken to get a ct scan and was not connected to the machine at the time of the incident.It was reported that during this time she observed saline from one of the clamped tubing sets leaking onto the power entry.The rapid infuser operator's manual states the following: "we strongly recommend loading and priming the disposable set just prior to the procedure." the unit was returned to belmont for investigation.Upon receipt it was noted that the power entry module in the system was damaged due to saline contamination.As fluid contamination may damage internal components, the operator's manual provides the following caution statement: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the operator's manual also instructs the user to check the unit seals every six months.The manual provides the following cleaning instructions: "inspect the seal around the unit to make certain it is in good condition.Check also the seal around the touch screen and ceramic disks.Use dow corning 732 multipurpose rtv sealant or equivalent if needed to maintain fluid resistance." the manufacturing records for this serial number were reviewed and no anomalies were identified.There was no injury to the patient.It was reported that the patient was not connected to the device at the time of the incident.Belmont will continue to monitor and trend similar reports of this nature.
 
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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
MDR Report Key9802743
MDR Text Key182469225
Report Number1219702-2020-00025
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,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
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 Manufacturer02/25/2020
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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