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

Model Number HYPERTHERMIA PUMP

Device Problem Intermittent Loss of Power (4016)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

The hyperthermia pump involved in the incident has not been returned to belmont for investigation, therefore a root cause of the reported power loss cannot be established.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.The unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2017.Without the ability to confirm the complaint, it is not possible to establish a root cause of the reported power loss.It was reported that another hyperthermia pump was used to finish the case; there was no injury to the patient.Belmont will continue to monitor and trend similar reports of this nature.Should the unit be returned for investigation, or additional information becomes available, a supplemental report will be provided.

Event Description

The user facility reported that the hyperthermia pump was frequently shutting down a case.Another hyperthermia pump was brought in to finish the case.There was no harm to the patient.

• 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: 11917100
• MDR Text Key: 267824769
• Report Number: 1219702-2021-00073
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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