MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE BLOOD/FLUID WARMER; THERMAL INFUSION FLUID WARMER

Model Number	BUDDY LITE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the buddy lite nor the associated disposable set have been returned to belmont for investigation.Follow up with the user facility revealed that the reported issue with the disposable set was a leakage of the microporous membrane, rather than a burst.This can occur if fluid is introduced prior to installing the disposable set into the heater unit, which is not in accordance with the instructions for use; however without investigating the device, a root cause of the reported leak or dislodged heater plate cannot be established.The following warning statements are provided in the operator's manual: "do not open the heater unit during or after priming" and "do not attempt to prime unit or subject the disposable to flow outside of the heater unit, as the disposable set will be damaged." the manufacturing records of the buddy lite were reviewed and no anomalies were identified.The batch records for the associated disposable set could not be reviewed, as no lot number was provided.All buddy disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.It was reported that there was no patient injury or delay in care as a result of the incident.Belmont has requested that the buddy lite be returned for further investigation.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's sales representative received a report from the user facility that the disposable set burst inside the buddy lite and dislodged the heating plate.

• Brand Name: THE BELMONT BUDDY LITE BLOOD/FLUID WARMER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11181317
• Report Number: 1219702-2021-00013
• Device Sequence Number: 16679419
• Product Code: BSB
• UDI-Device Identifier: 20896128002491
• UDI-Public: (01)20896128002491
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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: Health Professional
• Device Model Number: BUDDY LITE
• Device Catalogue Number: 905-00017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1