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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following receipt of the complaint, belmont's sales representative met with the chief perfusionist and we have continued to remain in contact with the user facility.The device has not been returned for investigation.The manufacturing records for this serial number were reviewed and nothing notable was found.When the device exhibits a "pump fault" alarm, the alarm message on the screen instructs the user: "check pump for blockage.Press retry to continue.Service machine if error persists." page 24 of the operator's manual also provides additional operator actions in the event of a "pump fault" alarm.We will continue to remain in contact with the user facility to obtain the unit for investigation, and will offer to provide further in-service training if necessary.It was reported that the case was finished successfully and that there was no harm to the patient, nor a delay in treatment.We will continue to monitor and trend reports of this nature.
Event or Problem Description
The user facility reported that the hyperthermia pump exhibited a "pump fault" alarm.Belmont's sales representative spoke with the chief perfusionist and relayed the following report: "we were on about 40 minutes warming and waiting for the chemo from pharmacy.About two minutes after i put the chemo in the pump it started making a loud clicking noise.I turned it off immediately and when brian and i looked over noticed a silver pin about 1 1/2 inches long laying in behind the pump.I clamped all the lines, opened the door and unloaded all the disposables from the raceway to get access to the roller head.I could see the loose roller hinge and was able to get the pin back in.I put the disposables back in and reloaded everything.Took the clamps off and went back on.Only off about 30-45 seconds.It worked fine but every 30 minutes or so the pin would start working back out but i could tap it back in without stopping the pump.".

• 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
• MDR Report Key: 8405927
• Report Number: 1219702-2019-00013
• Device Sequence Number: 13558231
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/08/2019

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1