MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	RI-2
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was received for evaluation on the date of this report; investigation of the device has not yet been completed.Without results of the investigation, it is difficult to determine what occurred in this case.The manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that a replacement unit was installed to continue the case.No patient injury was reported.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and relayed the following report: "the liver transplant surgery was scheduled on saturday, may 16th.The unit was prepared and the disposables (903-00004, 903-00006, and 903-00018) was attached and primed as usual.The unit was in operation and the surgery was going well until this problem came up.The unit had power failure and immediately shut down the system.The staffs tried to restart the system, but the power was completely gone.The staff contacted us the emergency assistance and we installed the replacement.".
Additional Manufacturer Narrative
The rapid infuser was returned for investigation and was tested according to our standard operating procedures.Upon receipt, four power transistors on the driver boards were shorted and damaged, which prevented the unit from powering up.We were unable to determine the root cause of the damaged transistors.The manufacturing records for this serial number were reviewed and nothing notable was observed.A review of complaints for the past three years indicates that this was an isolated incident.There was no patient injury reported.We will continue to monitor and trend similar reports of this nature and take further corrective action if required.Should additional information become available, a supplemental report will be submitted.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10171887
• Report Number: 1219702-2020-00046
• Device Sequence Number: 1659628
• Product Code: LGZ
• UDI-Device Identifier: 10896128002777
• UDI-Public: (01)10896128002777
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: RI-2
• Device Catalogue Number: 903-00039A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1