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	07/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The buddy disposable set was discarded and was therefore not available for investigation.Without reviewing photographs or investigating the set, it is difficult to determine the root cause of the leak.A visual inspection of the library/retain sample for this lot number was performed and no evidence of any defects was observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All buddy disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of complaints for the past three years indicates that this was an isolated incident.There have been no additional leaks reported with this lot number.There was no patient injury reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The biomed reported the following: "one of our flight crews were using the buddy lite fluid warmer and noticed that blood coming from the warmer plate area where the tubing attaches to the flat portion of the blood warmer tubing.Upon further investigation, it was found that one side of the flat portion of the blood warmer tubing that seats on the warmer plates had a defect.The membrane on the flat portion of the blood warmer tubing had a tiny area that was detached at the edge, where the blood enters the stated flat portion of the blood warming tubing.The buddy lite is not sealed, which allowed blood to get into the inner workings of the device.".

• 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: 10556374
• Report Number: 1219702-2020-00071
• Device Sequence Number: 3110662
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 11/30/2020
• Device Model Number: BUDDY DISPOSABLE SET
• Device Catalogue Number: 905-00010P
• Device Lot Number: 2017-11 04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1