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	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The buddy disposable sets were discarded and therefore not available for investigation.Without investigating the sets, it is difficult to determine the root cause of the leak.The manufacturing batch records for this lot 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.No patient injury was reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The user facility reported that two buddy disposable sets leaked during a case on (b)(6)2020.Both sets were discarded by the staff.

• 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: 10906323
• Report Number: 1219702-2020-00109
• Device Sequence Number: 2885202
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: (01)00896128002091(17)230430(10)20200401
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 04/30/2023
• Device Model Number: BUDDY DISPOSABLE SET
• Device Catalogue Number: 905-00010P
• Device Lot Number: 2020-04-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1