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

Model Number RI-2

Device Problem Flare or Flash (2942)

Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has not yet been returned to belmont for evaluation.Upon reviewing video footage of the incident provided by the user facility, the occurrence does not appear to be "an explosion/fire" as described, but rather a "flare or flash" that immediately self-extinguished.The manufacturing records for this serial number were reviewed and nothing notable was observed.The disposable set was not returned for evaluation, nor was a lot number provided.It was reported that the patient had suffered a serious trauma and that the rapid infuser did not contribute to patient injury.We will continue to follow up with the user facility about the return of the rapid infuser for evaluation, as well as information about the disposable set.Without additional information, it is difficult to determine what occurred in this case at this time.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Belmont's sales representative received a complaint from the user facility, who reported that after dropping their second unit of blood, the belmont sparked and then started smoking.Another infuser was brought in from the or and care was resumed.Photographs of the rapid infuser and a video of the incident were provided by the user facility.Upon following up with the user facility, it was reported that the staff was successfully giving two units of blood with no alarms when a flash occurred, which the users believe came from the power entry.The nurses reported that the unit continued infusing after the incident, the machine was subsequently unplugged, and the nurses began giving blood manually.It was reported that the patient did expire, but it was reported that the patient had suffered a serious trauma and the users did not believe that the rapid infuser contributed to any patient injury.

Manufacturer Narrative

Upon reviewing video footage of the incident provided by the user facility, the occurrence does not appear to be "an explosion/fire" as described, but rather a "flare or flash" that immediately self-extinguished.The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation, which revealed that the system power entry module and power cord were damaged due to a short circuit caused by saline contamination.Upon receipt it was also noted that there was a lot of saline inside the system, especially at the area where the power entry module is located.As fluid contamination may damage internal components, the operator's manual provides the following caution statement: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the operator's manual also instructs the user to check the unit seals every six months.The manual provides the following cleaning instructions: "inspect the seal around the unit to make certain it is in good condition.Check also the seal around the touch screen and ceramic disks.Use dow corning 732 multipurpose rtv sealant or equivalent if needed to maintain fluid resistance." the manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that the rapid infuser did not contribute to patient injury.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 9820993
• MDR Text Key: 183072294
• Report Number: 1219702-2020-00026
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1