MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY DISPOSABLE SET; BLOOD AND PLASMA WARMING DEVICE

Model Number	BUDDY LITE AC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set was not returned for investigation.Upon review of the photos provided by the user facility, it was noted that fluid was being introduced when the buddy disposable set was not installed in the heater unit.This is not recommended by belmont.The following warning statements are provided on page 7 of the buddy lite ac operator's manual: (1) "do not open the heater unit during or after priming" and (2) "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 batch records for this lot were reviewed with no anomalies identified.All buddy disposable sets are 100% leak tested prior to being released for use.The retain sample for this lot was visually inspected, a standard leak test was performed, and fluid was also introduced via a gravity feed.No leaking was observed.The sales manager has gone to the user facility to provide additional user training.We did not receive any reports of patient injury.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that while using the belmont buddy disposable sets, the staff noticed that the set was leaking.The user tested a new set and found that set was also leaking from the side.

• Brand Name: THE BELMONT BUDDY DISPOSABLE SET
• Common Device Name: BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 8714351
• Report Number: 1219702-2019-00040
• Device Sequence Number: 2663518
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: (01)00896128002091
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 01/31/2022
• Device Model Number: BUDDY LITE AC
• Device Catalogue Number: 905-00010P
• Device Lot Number: 2019-01 02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1