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

Model Number	BUDDY DISPOSABLE SET
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The buddy disposable set involved in the incident was not available for investigation.Without investigating the set, a root cause of the reported leak cannot be established.The manufacturing batch records for this lot number were reviewed and no anomalies were identified.A review of past complaints indicates that there have been no other reports related to this lot number.No trend has been identified for this issue.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 documentation to support hypothermia; no patient harm was reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont medical technologies received user facility report number (b)(4) from the fda, describing the following event which reportedly occurred on (b)(6)2020: "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: THE BELMONT BUDDY LITE 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: 12284920
• Report Number: 1219702-2021-00104
• Device Sequence Number: 19543054
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: (01)00896128002091(17)231031(10)20191002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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 Expiration Date: 10/31/2022
• Device Model Number: BUDDY DISPOSABLE SET
• Device Catalogue Number: 905-00010P
• Device Lot Number: 2019-10 02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1