MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE; THERMAL INFUSION FLUID WARMER

Catalog Number 905-00018

Device Problems Overheating of Device (1437); Infusion or Flow Problem (2964); Temperature Problem (3022)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

The internal complaint file # (b)(4) has been logged for this incident for traceability.Incident was initially reported to belmont to belmonton 27 nov 2023.The only detail provided was"overheating".No additional information wasprovided.Based upon the information providedbelmont documented the incident.Subsequent mir2024/001/016/501/006 received 17 jan 2024 containing more information about the alleged incident."fluid warmer used for a hypotensive and hypothermic patient.The warmer over heated and the iv fluids came out too hot.Fluid warmer disconnected.Felt hot to the touch and once open edit smelt of burning plastic." datix ref: wf129599.Device did not fail safe.Initial review indicates that no patient harm /impact occurred as a result of the alleged incident.Belmont confirmed that the device was available for inspection and it has been sent to usa for inspection.Initial review of the device in the uk indicates that only one of the two heating plate is working.A review of complaints indicates no other incidents of this kind have been received.This is confirmed as an isolated incident.A review of the device history for the device in question indicates no other issues.When the buddy lite functions normally, the green led on the heater unit will blink with each heating cycle.An over temperature condition causes the unit to stop heating, the green led stops blinking, and an alarm alert will be activated, and the blue/red led will flash alternately.Under alarm conditions, an audible alarm is activated and the blue/red led flashes.Alarm conditions include-over temperature, probe fault, check for air, and no heat.The operator's manual also provides possible conditions, additional recommended operator actions and routine maintenance requirements.Routine maintenance consists of cleaning and inspecting the heater unit, recharge the battery after each use, recalibrate the battery fuel gauge, and testing the system operational.Further follow up with the user will be conducted to determine if there are any other details.The device will be returned to belmont manufacturing location in usa to determine if the reported incident can be confirmed and if a root cause can be established.A follow-up report will be submitted once the investigation is complete and if additional information becomes available.

Event Description

On 17 january 2024belmont medical technologies received mir reference number 2024/001/016/501/006 detailing an incident that occurred (b)(6) 2023."fluid warmer used for a hypotensive and hypothermic patient.The warmer over heated and the iv fluids came out too hot.Fluid warmer disconnected.Felt hot to the touch and once opened it smelt of burning plastic." datix ref: wf129599.Workshop testing was able to replicate the fault: one of the two heat plates wasn't working and the other kept increasing in temperature without cutting out for an over temperature situation.Device did not fail safe.

Manufacturer Narrative

The cited device was reviewed by a belmont service technician.It was found only 1 of the heater plates were working.During further testing, it was found that the output fluid temperature was 24 degrees celsius and fluid was not overheated.The reported issue of the fluids coming out too hot could not be verified.It was additionally found the housing of the device was cracked.The unit exhibited no other faults/failures.No patient harm was noted.Evaluation: the heater plate and housing were replaced to resolve the one heater plate that was found to be not working.Belmont performed a final functional test, and the unit passed all test specifications and inspection requirements.The buddy lite contains 6 separate temperature measurement elements, 3 on each plate.Each plate has an input and output thermistor that measures the fluid entering and exiting the system.These thermistors are used as inputs to a microprocessor that controls a single output switch transistor and is under software control to regulate the output temperature to 38 degrees c.Additionally there is a dedicated temperature measurement ic (an lm75) that monitors the board temperature and independently controls a separate output switch to operate as an over temperature shutdown.Note in order for the system to heat both control systems need to enable each separate output switching transistor to energize the heater resistor.The reported issue of overheating could not be confirmed.During further testing, it was found that the output fluid temperature was 24 degrees celsius and fluid was not overheated.The cited incident could not be confirmed, testing determined that the device was not found to be overheating.The cause of one of the heater plates to be non operational could not be confirmed, although it was noted that housing of the device was cracked.The heater plate and housing were replaced to resolve the non operational heater plate.We performed a final functional test, and the unit passed all test specifications and inspection requirements.Belmont will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: THE BELMONT BUDDY LITE
• 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
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 18684864
• MDR Text Key: 335116918
• Report Number: 1219702-2024-00006
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 905-00018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1