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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump was returned to (b)(4) for investigation; evaluation of the unit is in process.During troubleshooting, the hospital biomed was able to confirm a loose connection between the power cord and the power entry, which likely caused the system to switch to battery operation as reported by the user.The system automatically switches to battery operation if the ac power is interrupted, and can operate in battery mode for a short period of time.An audible alarm sounds every 10 seconds to alert user that the system is in battery operation and requires intervention.The manufacturing records for this serial number were reviewed and no anomalies were identified during the manufacturing process.It was reported that the user was able to complete the case; no patient injury was reported.A review of past complaints indicates that no trend has been identified for this type of issue.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that while the hyperthermia pump was in use, the user experienced a battery operate error intermittently but was able to finish the case after adjusting the power cord and repowering the unit.During troubleshooting, the hospital biomed was able to confirm a loose connection between the power cord and the power entry.
Additional Manufacturer Narrative
The hyperthermia pump was returned to belmont for investigation.The reported "battery operate error" could not be confirmed after extensive testing; the unit performed according to specifications upon receipt.During troubleshooting, the hospital biomed identified a loose connection between the power cord and the power entry, therefore belmont replaced the system power cord.The loose connection was likely what caused the system to switch to battery operation as reported by the user.The system automatically switches to battery operation if the ac power is interrupted, and can operate in battery mode for a short period of time.An audible alarm sounds every 10 seconds to alert user that the system is in battery operation and requires intervention.The manufacturing records for this serial number were reviewed and no anomalies were identified during the manufacturing process.It was reported that the user was able to complete the case; no patient injury was reported.A review of past complaints indicate will continue to monitor and trend similar reports of this nature.

• 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
• 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: 10805369
• Report Number: 1219702-2020-00094
• Device Sequence Number: 3814682
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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 Model Number: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown