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

Model Number RI-2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.Upon receipt, it was noted that several transistors on the driver boards were shorted, which caused the circuit breaker to trip.Without additional information, it is difficult to determine why the transistors were damaged.Further testing is being conducted.The operator's manual instructs the user, "ensure that the circuit breaker is easily accessible to turn off in an emergency situation" upon powering up the unit.It was reported that the implicated unit was immediately swapped out with another rapid infuser; there was no patient injury reported.We have remained in communication with our distributor to obtain additional information.Should additional information become available, a supplemental report will be submitted.

Event Description

Our distributor received a complaint from the user facility and relayed the following report: "during a case, the ri-2 suddenly stopped running on ac and was in battery operation.We checked and found out the power outlet was tripped, this happened only after 4 hours through the case.Immediately we swapped to another fms for backup.".

• 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: 9365870
• MDR Text Key: 195084944
• Report Number: 1219702-2019-00089
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002753
• UDI-Public: (01)10896128002753
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2019

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 Number: RI-2
• Device Catalogue Number: 903-00037A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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