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

Model Number RI-2

Device Problem Sparking (2595)

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

Event Date 05/24/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.Upon receipt, we found that the power cord was damaged and needed to be replaced, which was likely the cause of the spark as reported by the user.When tested with a functional power cord, the unit performed according to our specifications.We were unable to investigate the disposable set, as the set was discarded at the hospital and the lot number was not available.The power cord should be checked before or after each use, according to the service and preventive maintenance schedule provided in the operator's manual.The routine maintenance instructions provided in the manual instruct the user to: "inspect the power cord along its length and connectors for cuts and breaks.Replace power cord if damaged." it was reported that there was no injury to the patient.The manufacturing records for this serial number were reviewed and nothing notable was observed.Should additional information become available, a supplemental report will be submitted.

Event Description

The hospital biomed reported the following: "while in a gsw trauma in or 2 a 120ml belmont was being used to rapidly infuse the hemorrhaging patient.The belmont was being run at 500ml/minute when staff noticed that the belmont began smoking with subsequent small sparks.The belmont was immediately turned off, unplugged, and disconnected from the patient.Since the severity of the issue was unknown the belmont was placed in the or hallway in the case a fire erupted.After the trauma was over i took pictures of the belmont, where i noticed that the plastic insides where melted." it was reported that the biomed subsequently inspected the rapid infuser and found a split/crack on the end of the power cord where it plugs into the back of the unit.

• 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: 10191929
• MDR Text Key: 197963992
• Report Number: 1219702-2020-00048
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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: 903-00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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