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

Model Number HYPERTHERMIA PUMP

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The hyperthermia pump involved in the incident has not been returned to belmont for investigation, therefore we are unable to confirm that the vacuum regulator intermittently stops functioning.The vacuum regulator is an accessory that can be used along with a hospital supplied vacuum source to allow regulation of the fluid levels of the large reservoir, and allows the user to increase the vacuum supplied to the reservoir and consequently increase return volume from the patient to the reservoir.The manual provides the following instructions: "if the vacuum regulator, ref (b)(4), is used, screw the trap into the regulator then clamp this assembly a few inches above the reservoir holder.Make certain that there is nothing obstructing the air vents at the bottom of the system." without the ability to investigate the unit, a root cause cannot be established.A review of past complaints indicates that this was an isolated incident.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.It was reported that there was no harm 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 Description

The user facility reported that the hyperthermia pump vacuum regulator stopped working intermittently during the last several hyperthermia procedures.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Type of Device: 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 12146548
• MDR Text Key: 261520738
• Report Number: 1219702-2021-00092
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1