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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable set was not available to be returned for investigation; however, upon reviewing the photograph provided by the user we were able to confirm that there were kinks in the tubing.Without evaluating the sample, it is difficult to determine what caused the kinks.The library/retain sample for this part number/lot number was inspected and no kinks were observed.The manufacturing batch records for this lot number were also reviewed and no anomalies were found.A review of complaints for the past year indicated no additional reports of this nature; this appears to be an isolated incident.All finished disposable sets are 100% visually inspected.It was reported that the case was completed successfully with the implicated set; there was no harm to the patient.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "during the case on (b)(6) 2020, a continuous hi-pressure alarm was received during the case.Greg checked the tubing between the belmont hypothermia pump and the patient without finding a kink.He said the pressure was around 170 mmhg, so i had him check the tubing between the 4.4-liter canister and the top of the machine.He found some kinks, after applying pressure to the kinks to round them out, the alarms quit.The case was finished without incident.".

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10121863
• Report Number: 1219702-2020-00045
• Device Sequence Number: 16875113
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: 10896128002456
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: 03/31/2023
• Device Model Number: PROCEDURE KIT
• Device Catalogue Number: 902-00045
• Device Lot Number: 2020-03 17
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1