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

Model Number	905-00010P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set was not returned for investigation.The retention sample of the associated lot was reviewed and tested, including leak testing and introducing fluids to the sample, and nothing notable was identified.There were no leaks observed.All buddy disposable sets manufactured are 100% leak tested prior to release.The manufacturing records of the associated lot were also reviewed and there were no anomalies related to the pressure relief valve observed.A review of complaints for the past year indicated no trend of this failure mode.No patient injury was reported.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the crna experienced fluid leaking from the pressure release valve on the buddy disposable set.

• 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: 8680845
• Report Number: 1219702-2019-00036
• Device Sequence Number: 11264111
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: (01)00896128002091
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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 Expiration Date: 03/31/2021
• Device Model Number: 905-00010P
• Device Catalogue Number: 905-00010P
• Device Lot Number: 2019-03 06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1