MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER

Model Number	PROCEDURE KIT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set involved in the incident has not been returned to belmont for investigation.The photograph provided by the user facility confirms the reported kink in the tubing, however without evaluating the set a definitive root cause of the kink cannot be determined.The library/retain sample for this lot number was visually inspected and did not display this defect.The manufacturing batch records for this lot were also reviewed and no related anomalies were identified.A review of past complaints indicates no other complaints related to this lot number.This was an isolated incident, there have been no other reports of this nature related to this product.It was reported that the disposable set was replaced; there was no injury to the patient.Belmont will continue to monitor and trend similar reports of this nature.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user reported that the belmont hyperthermia pump procedure kit had a kink in the drainage tubing and would not flow during set up.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11350910
• Report Number: 1219702-2021-00026
• Device Sequence Number: 728430
• Product Code: LGZ
• UDI-Device Identifier: 00896128002589
• UDI-Public: (01)00896128002589(17)230430(10)20200413
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 04/30/2023
• Device Model Number: PROCEDURE KIT
• Device Catalogue Number: 902-00045
• Device Lot Number: 2020-04 13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1