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 Code Available (3191)

Event Date 03/07/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has not been returned for investigation.Upon following up with the user facility, it was determined that the rapid infuser did not malfunction; the patient expired due to the injury prompting the er visit.It was reported that in the event of a patient death, it is hospital policy to document the serial numbers of all machines used.No additional information was provided.The manufacturing records for this serial number were reviewed and nothing notable was observed.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont's sales representative received an inquiry from the user facility and reported that the user called to request the serial number of the rapid infuser, as hospital policy requires documenting id numbers of all machines used in the event that a patient passes.The patient expired due to the injury prompting the er visit.The rapid infuser did not malfunction.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 9933627
• MDR Text Key: 198522826
• Report Number: 1219702-2020-00033
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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