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

Model Number	BUDDY LITE AC
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation, nor has the serial number or lot number been provided.We have reached out to the user facility on several occasions to obtain additional information, but none has been received.Without additional information, it is difficult to determine what occurred in this case.We will continue to follow up with the user facility to ask for additional information.The belmont sales representative and clinical specialist have remained in contact with the user facility to offer further in-service training.Should additional information become available, a supplemental report wil be submitted accordingly.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "there was another fire with the buddy light tonight, in another or.I questioned the comment and received back on the 16th 'good afternoon, atrium is performing a risk assessment on the event.I believe the unit is with ge/biomed.I am awaiting their review myself.'.

• Brand Name: THE BELMONT BUDDY LITE BLOOD/FLUID WARMER
• Common Device Name: BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd.; billerica MA 01821
• MDR Report Key: 8701497
• Report Number: 1219702-2019-00038
• Device Sequence Number: 2446210
• Product Code: BSB
• UDI-Device Identifier: 10896128002449
• UDI-Public: 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): 06/14/2019

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: 905-00022R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1