MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	PROCEDURE KIT
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set involved in the incident was not available for investigation.A review of photographs provided verifies the reported crack in the tubing, however without investigating the set it is difficult to determine the root cause of the crack.The library/retain sample for this lot number was visually inspected and no defects were observed.The manufacturing batch records for this lot were also reviewed and no related anomalies were identified.All disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there have been no other complaints related to this lot number.It was reported that the disposable set was replaced and the procedure was completed without issue; there was no injury to the patient.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and reported the following: "sorry to inform that we have found a faulty/defective of, 902-00045 belmont hyperthermia pump procedure pack kit during the case on (b)(6) 2020 in (b)(6) medical centre by dr.(b)(6) in (b)(6) (lot: 2019-1113).We discover that the solution starts to leak from the machine once start pumping and there is a crack on the tubing.The case was continued by replacing the disposable set and it was done smoothly after that.".

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11041240
• Report Number: 1219702-2020-00117
• Device Sequence Number: 16402422
• Product Code: LGZ
• UDI-Device Identifier: 00896128002589
• UDI-Public: (01)00896128002589(17)221130(10)20191113
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 11/30/2022
• Device Model Number: PROCEDURE KIT
• Device Catalogue Number: 902-00045
• Device Lot Number: 2019-11 13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1