MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE AC BLOOD/FLUID WARMER; BLOOD AND PLASMA WARMING DEVICE

Model Number	BUDDY LITE AC
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The buddy lite ac involved in the incident has not been returned to belmont for investigation.The user facility reported that while trying to clean the device, the user sprayed the ac adapter with cavicide without unplugging it from the electrical outlet, which caused a short circuit on the power supply and resulted in sparks and smoke.It was reported that or leadership conducted a review of proper cleaning procedures with or personnel.The device has not been returned to belmont for further investigation.The manufacturing records for this serial number were reviewed and no anomalies were identified.Instructions for cleaning, disinfection, and maintenance are provided in the operator's manual.The manual instructs the user to wipe down the battery housing and ac/dc power supply with water or a 10% bleach solution using a soft cloth, and states the following: "avoid the use of acetone or other solvents that may damage the surface." the manual also provides the following warning: "do not submerge the heater unit.Practice standard hospital policy when handling blood products.Treat blood as if it were infected and clean up all spills immediately." it was reported that the procedure was already completed at the time of the incident; there was no injury to the patient.A review of past complaints indicates that this was an isolated incident.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont medical technologies received the following medwatch report (uf/importer report # (b)(4)) from the department of health & human services: "the ac adapter of the belmont buddy lite fluid warmer became wet with blood.While trying to clean the device, the user used cavicide and sprayed the ac adapter without unplugging it from the electrical outlet, causing a short circuit on the power supply that generated sparks and smoke in the operating room (or).The or procedure was already completed at the time of the incident, no patient or user were harmed by this situation.The ac adapter and belmont buddy lite were removed from service.Or leadership conducted a procedure review with or personnel to review proper cleaning procedures of equipment that are contaminated with biological fluids.".

• Brand Name: THE BELMONT BUDDY LITE AC BLOOD/FLUID WARMER
• Common Device Name: BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11829429
• Report Number: 1219702-2021-00067
• Device Sequence Number: 17027991
• Product Code: BSB
• UDI-Device Identifier: 10896128002449
• UDI-Public: (01)10896128002449
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: BUDDY LITE AC
• Device Catalogue Number: 905-00022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1