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

Model Number	RI-2
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has been returned to belmont for evaluation.Evaluation of the unit is in process; a follow-up report will be submitted.At each start-up, the rapid infuser automatically checks whether the temperature probe, pressure sensor, or power module have lost calibration information.If any one of the hardware parameters has lost calibration, the system goes directly into the calibration/set-up screen upon start-up and the system will not exit the calibration/set-up mode until it is calibrated.However, without results from the complete investigation, it is difficult to determine what occurred.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: "during a major resuscitation this morning, the device failed on startup.It went straight to the calibration/set-up screen and the exit service button did not respond.They rebooted the ri-2 computer and changed the ac power source repeatedly however it did not resolve the error.".
Additional Manufacturer Narrative
The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.Upon receipt, we found that two pins on the feedback cable had been damaged, which caused the unit to lose its calibration parameters and go straight to the calibration/set-up screen at start-up as reported by the customer.The device performed as intended; at each start-up, the rapid infuser automatically checks whether the temperature probe, pressure sensor, or power module have lost calibration information.If any one of the hardware parameters has lost calibration, the system goes directly into the calibration/set-up screen upon start-up and will not exit the calibration/set-up mode until it is calibrated.The manufacturing records for this serial number were reviewed and nothing notable was observed.There was no patient injury or delay in treatment reported.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: 10311705
• Report Number: 1219702-2020-00053
• Device Sequence Number: 3398703
• Product Code: LGZ
• UDI-Device Identifier: 10896128002777
• UDI-Public: (01)10896128002777
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/22/2020

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: 07/07/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/22/2020
• 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