MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 905-00022

Device Problems Leak/Splash (1354); Smoking (1585); Sparking (2595); Electrical Shorting (2926)

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

Event Date 03/30/2021

Event Type  malfunction  

Event Description

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 operating room 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.Operating room leadership conducted a procedure review with operating room personnel to review proper cleaning procedures of equipment that are contaminated with biological fluids.

• Brand Name: BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston rd; billerica MA 01821
• MDR Report Key: 11612730
• MDR Text Key: 243747257
• Report Number: 11612730
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 10896128002449
• UDI-Public: (01)10896128002449
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 905-00022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1