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

Model Number RI-2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has not been returned to belmont for investigation.The medwatch report stated that the rapid infuser "would not work" but no description of the error was provided.A review of the manufacturing records could not be completed, as the serial number was not made available.No patient injury was reported; the unit was replaced with another rapid infuser and was used without issues.It was reported that the hospital biomed evaluated the unit and was unable to reproduce the problem.Without additional information, it is difficult to determine what occurred in this case.Belmont has contacted the initial reporter to obtain details about the incident but has not yet received a response.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, about an event that reportedly occurred in (b)(6) 2020: "belmont rapid infuser would not work when preparing for patient.A second belmont in department was used without issues.Original belmont sent to and evaluated by biomed.Biomed was unable to reproduce stated issue.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 10610928
• MDR Text Key: 230281784
• Report Number: 1219702-2020-00079
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1