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 Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.We have reached out to the user facility for additional information and to request that the unit be returned for evaluation.A review of the manufacturing records indicated nothing notable.We have reached out to the user facility to determine the lot number of the disposable set, as the lot number was not provided.The disposable set in the photographs provided appeared to be unused.Without additional information, it is difficult to determine what occurred in this case.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
The user facility reported that the buddy lite ac cartridge overheated.

• 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: 8622419
• Report Number: 1219702-2019-00032
• Device Sequence Number: 2168413
• Product Code: BSB
• UDI-Device Identifier: 10896128002449
• UDI-Public: (01)10896128002449
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: BUDDY LITE AC
• Device Catalogue Number: 905-00022
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1