MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION BUDDY DISPOSABLE SET; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number	905-00010P
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Used the buddy lite to warm fluids (burn patient), loaded the cassette, primed the line, attached it to the patient, and turned it on (ivf [intravenous fluids] not under pressure, just wo).When on, finally noticed fluid leaking.Iv locked and fluids locked.After transfer of pt to trauma bed and everything settled down, disconnected the buddy lite from pt, iv was flushed and patent.Buddylite disposable set ref 905-00010p.Tubing was stopped and removed from patient use.Iv was flushed without incident and infusion continued.No documentation to support hypothermia.Admitted to icu and discharged, to follow up with burn clinic.

• Brand Name: BUDDY DISPOSABLE SET
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston rd; billerica MA 01821
• MDR Report Key: 12066171
• Report Number: 12066171
• Device Sequence Number: 3909959
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: (01)00896128002091(17)221031(10)20191002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021
• Report Date (Section F): 06/15/2021

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?: Yes
• Operator of Device: Other
• Device Model Number: 905-00010P
• Device Lot Number: 20191002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/15/2021