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

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bruise/Contusion (1754)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hyperthermia pump involved in the incident has not been returned to belmont for investigation.There were no photographs provided of the reported lesions.A review of past complaints indicates that this was an isolated incident; this is the first time belmont has received a report of this nature.Initial review of the information provided appears to indicate that the user did not follow typical medical procedure.It was reported that the suction was not turned down prior to connecting to the cannulas.It is the responsibility of the clinical staff to ensure the placement and level of suction is within recommended levels.The operator's manual provides the following disclaimer: "proper surgical procedures and techniques are the responsibility of the medical profession.The described procedure is furnished for information purposes only.Each surgeon must evaluate the appropriateness of the procedure being used based on their own medical training and experience and the type of surgical procedure being performed." there was no report of any issues with the device itself.A review of the manufacturing and service records for this serial number indicated that the unit was returned twice in 2015 for loss of calibration, which was traced to damage likely due to an accidental impact and lack of proper routine maintenance.The unit has not been returned to belmont for service since 2015.There is no evidence to suggest that the device malfunctioned to contribute to patient injury.Belmont will continue to monitor for similar reports of this nature.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's clinical specialist received a report involving a hyperthermia pump and relayed the following: "received a phone call from (b)(6) to notify belmont that after a hypothermia case, a patient had lesions left on the bowel.The lesions were noticed when the patient's abdomen was opened and the cannulas had become attached to the bowel of the patient from the suction.The device was being operated by (b)(6), perfusionist, and the suction was not turned down prior to connecting it to the cannulas.".

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• MDR Report Key: 12321736
• Report Number: 1219702-2021-00113
• Device Sequence Number: 4980931
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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