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

Catalog Number 403-00306R

Device Problems Overheating of Device (1437); Unable to Obtain Readings (1516)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported by the biomed that the external temperatures from the system displayed n/a with no temperature readout.

Manufacturer Narrative

The internal complaint file # (b)(4) has been logged for this incident for traceability.The hyperthermia pump involved in the incident has been returned to belmont medical technologies for evaluation on 10/28/2022.The disposable used was not returned.Belmont received mw5113024 for this incident on 11/04/2022.It was reported by the biomed that the external temperatures from the system displayed n/a with no temperature readout.The medwatch subsequently also indicated overheating of the device.We reached out to the user facility for further information on 11/04 and 11/16 and it was confirmed by the user facility on 11/21 that there was no patient injury associated with the use of device in this incident.In the event of an "over temperature" alarm, the hyperthermia pump displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions, which includes checking for restricted flow or a clogged filter.The manual also provides possible conditions and recommended operator actions in the event that the flow rate is slowing down or will not go at the set rate.The manufacturing records for the hyperthermia pump were reviewed and no anomalies were identified.It was confirmed that there was no injury to the patient.The cited device was returned and evaluated at belmont, the disposable used was not returned.It was identified that pin-8 on the connector of the four channel sensors was loose, which caused the unit to be unable to detect the external temperature from the ext temperature probes, and therefore, displayed as n/a.The unit exhibited no other faults/failures.The connector on the four channel sensors was repaired by belmont's service engineer to ensure that the device performs as per our specifications.The unit passed all test specifications and inspection requirements.No root cause could be attributed for the cause of the loose connector.No additional malfunctions were identified and the claim of overheating could not be confirmed or replicated.Review of complaints shows this is an isolated incident.We will continue to monitor and trend similar reports closely and take further corrective and preventive actions if required.

• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 15883460
• MDR Text Key: 307768231
• Report Number: 1219702-2022-00043
• Device Sequence Number: 1
• Product Code: LGZ
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403-00306R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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