MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE; THERMAL INFUSION FLUID WARMER

Model Number	403-00340
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file # cmp- (b)(4).Has been logged for this incident for traceability.Belmont received the buddy lite unit involved in the incident back for investigation on 04/18/2022.It was confirmed on 05/02/2022.That the buddy lite device did not injure the patient.When the buddy lite functions normally, the green led on the heater unit will blink with each heating cycle.An over temperature condition causes the unit to stop heating, the green led stops blinking, and an alarm alert will be activated, and the blue/red led will flash alternately.Under alarm conditions, an audible alarm is activated and the blue/red led flashes.Alarm conditions include-over temperature, probe fault, check for air, and no heat.The operator's manual also provides possible conditions, additional recommended operator actions and routime maintenance requirements.Routine maintenance consists of cleaning and inspecting the heater unit, recharge the battery after each use, recalibrate the battery fuel gauge, and testing the system operational.Upon receipt of the referenced buddy lite unit, we were unable to confirm the customer complaint after extensive testing.The buddy lite system performed according to our specifications without any problems.The buddy disposable set was not returned to belmont for evaluation.Therefore; a thorough investigation into the disposable set is not possible.All buddy disposable sets are 100% visually inspected and 100% leak tested prior to final packaging by belmont medical technologies.A review of past complaints indicates there have been no other reports of this nature that has lead to breakage of cartridge.No trend has been identified for this type of issue.There is no known injury to the patient.If additional information becomes available, a follow-up report will be provided.
Event or Problem Description
It was reported that the buddy lite was being used via an intraosseus access point and that the cartridge broke after 5 minutes of use.The buddy lite was discontinued and the remaining blood product was pushed unwarmed through a new peripheral access point.

• Brand Name: THE BELMONT BUDDY LITE
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821 ; 9786630212
• MDR Report Key: 14296173
• Report Number: 1219702-2022-00017
• Device Sequence Number: 20185706
• Product Code: BSB
• UDI-Device Identifier: 00896128002497
• UDI-Public: 00896128002497
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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: 11/01/2019
• Device Model Number: 403-00340
• Device Catalogue Number: 403-00340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown