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

Model Number RI-2

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident has not been returned to belmont for investigation.The hospital biomed subsequently provided an update that the user did not engage the power switch properly and the unit would therefore not be returned for investigation.The operator's manual provides the following instructions for powering on the system: "turn power on by firmly pressing the circuit breaker to the on position.The system will perform a self-check to check the integrity of system parameters; ac power present appears at the logo screen when the system first powers up.Check the power cord and ac receptacle connections if the statement does not appear; prime screen will appear; press next to go to the prime screen." the alarms and troubleshooting guide in the manual provides possible conditions and recommended operator actions in the event that the system powers off immediately or 2-3 seconds after being switched to on.In the case of an accidental power off, the system displays the following message on the screen: "please stop the pump before turning the power off.Turn the circuit breaker back on." without investigating the unit it is not possible to confirm whether there are any anomalies with the device.The manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that the incident occurred during preparation before a case and another rapid infuser was brought in to use for the procedure; there was no harm to the patient.Should additional information become available, a supplemental report will be provided.

Event Description

The user facility reported that during preparation before a case, the belmont rapid infuser, ri-2 was turned on briefly and then shut itself off.Another rapid infuser was used for the case; there was no harm to the patient.

• 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 Key: 11904849
• MDR Text Key: 266928134
• Report Number: 1219702-2021-00074
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1