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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient injury reported.It was reported that the disposable set could not be returned for investigation.The hardware device was received by belmont on october 29, 2018 for evaluation.The investigation is not yet complete.A follow-up report with all additional relevant information will be submitted upon completion of the investigation.
Event or Problem Description
The distributor emailed the following details about an event that occurred involving a hyperthermia pump: "the system suction regulator is not working.We are not able to maintain our reservoir content and the fluid keeps depleting.We have used 2 different types of suction source and both sources are working perfectly.We have intermittently turned on the suction regulator hoping to stabilize the return flow, the surgical team has also reopened the patient's abdomen, changed all the disposables in order to rectify the connection but nothing seemed to work.It took us 2 hours, 5pm-7pm to rectify but it all did not work.To make the story short, hipec procedure has been terminated and will only be done until a good system arrives.".

• 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: 8035387
• Report Number: 1219702-2018-00039
• Device Sequence Number: 1187746
• Product Code: LGZ
• UDI-Device Identifier: 10896128002135
• UDI-Public: (01)10896128002135
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: 902-00001A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1