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

Model Number RI-2

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

Belmont medical technologies received an initial report from the user facility on (b)(6) 2021, and subsequently received a copy of the medsun report #(b)(4) from the user facility on april 12, 2021.It was reported that the ri-2 was set up for an or trauma case and the clinical staff noticed flames coming from the back of the device.The user facility reported that the initial assessment pointed to the device power plug as the source of failure, and that liquid around the power cord or a loose power connection may have been contributing factors.The user facility has voluntarily suspended use of the ri-2 units.As of the date of this report we have not received the device back from the hospital.The manufacturing records for this serial number were reviewed and no anomalies were identified.Without the benefit of the device back at our facility for further investigation, we note the following: 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." when powering on the system, the operator's manual instructs the user: "check that the detachable power cable is securely seated in the main power receptacle; ensure that circuit breaker is easily accessible to turn off in an emergency situation; plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." as fluid contamination may damage internal components, the service and preventive maintenance schedule outlined in the operator's manual instructs the user to check the unit seals every six months.The operator's manual also provides the following caution statement: "immediately wipe any spills from device." there was no patient injury reported.Belmont medical technologies is in contact with the user facility and is actively investigating to establish a root cause.A review of past complaints indicates that similar occurrences have been reported a total of five times since the ri-2 was placed on the market in 2015.Through our investigation, all five occurrences were traced to saline contamination as a result of improper routine or preventive maintenance.When additional information becomes available, a supplemental report will be provided.

Event Description

On (b)(6) 2021, belmont medical technologies received the following report from the clinical engineering manager at the user facility: "last night, (b)(6) hospital had a fire with one of our belmont rapid infuser ri-2's that had to be put out with a fire extinguisher.It appears that the fire originated from where the power cord plugged into the machine." on april 12, 2021, the user facility subsequently provided a copy of the medsun report, which stated the following: "a belmont rapid infuser ri-2 was set up for an or trauma case and the clinical staff noticed flames coming from the back of the device.It was put out with an extinguisher, the fire department called, and the device sequestered.Initial assessment points to the device power plug being the source of failure.Contributing factors may include liquid around the power cord or a loose power connection.Dph has requested that all belmont rapid infusers ri-2 devices be pulled from use until the vendor determines the root cause and clears them for use.".

Manufacturer Narrative

Belmont medical technologies received an initial report from the user facility on april 4, 2021, and subsequently received a copy of the medsun report #(b)(4) from the user facility on april 12, 2021.It was reported that the ri-2 was set up for an or trauma case and the clinical staff noticed flames coming from the back of the device.The user facility reported that the initial assessment pointed to the device power plug as the source of failure, and that liquid around the power cord or a loose power connection may have been contributing factors.The user facility has voluntarily suspended use of the ri-2 units.As of the date of this report we have not received the device back from the hospital.The manufacturing records for this serial number were reviewed and no anomalies were identified.Without the benefit of the device back at our facility for further investigation, we note the following: 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." when powering on the system, the operator's manual instructs the user: "check that the detachable power cable is securely seated in the main power receptacle; ensure that circuit breaker is easily accessible to turn off in an emergency situation; plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." as fluid contamination may damage internal components, the service and preventive maintenance schedule outlined in the operator's manual instructs the user to check the unit seals every six months.The operator's manual also provides the following caution statement: "immediately wipe any spills from device." there was no patient injury reported.A review of past complaints indicates that similar occurrences have been reported a total of five times since the ri-2 was placed on the market in 2015.Through our investigation, all five occurrences were traced to saline contamination as a result of improper routine or preventive maintenance.Belmont medical technologies is actively investigating to establish a root cause and have followed up with the user facility for status updates/additional information on the following occasions: (b)(6) 2021.Initial telephone calls on 4/5 to obtain information about the incident were followed by an in-service on 4/6 of all facilities using the ri-2.Belmont's clinical specialist subsequently hosted a zoom meeting on 4/28 with hospital nursing staff and biomed at all facilities to review prescribed routine maintenance of the ri-2 as outlined in the operator's and service manuals.Belmont technical support reached out to the user facility on 5/13 and were informed that while access to the device was not allowed, belmont would be notified of the opportunity to observe investigation of the device.On 6/3 the hospital's clinical engineering manager reported that the device may be released for investigation with belmont, however subsequent follow-ups for status updates were unsuccessful.On 6/25 belmont's sales representative became aware that his point of contact, the clinical engineering manager, is no longer with the hospital.He subsequently spoke with the manager of clinical engineering for the main campus, who reported that the ri-2 was sent to ecri for investigation.Belmont has followed up with the user facility to determine when the device was sent to ecri, the status of the ecri investigation, and the expected completion date.A follow-up report will be provided as additional information becomes available.

Manufacturer Narrative

Belmont medical technologies received an initial report from the user facility on april 4, 2021, and subsequently received a copy of the medsun report #(b)(4) from the user facility on april 12, 2021.It was reported that the ri-2 was set up for an or trauma case and the clinical staff noticed flames coming from the back of the device.The user facility reported that the initial assessment pointed to the device power plug as the source of failure, and that liquid around the power cord or a loose power connection may have been contributing factors.The user facility has voluntarily suspended use of the ri-2 units.As of the date of this report we have not received the device back from the hospital.The manufacturing records for this serial number were reviewed and no anomalies were identified.Without the benefit of the device back at our facility for further investigation, we note the following: 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." when powering on the system, the operator's manual instructs the user: "check that the detachable power cable is securely seated in the main power receptacle; ensure that circuit breaker is easily accessible to turn off in an emergency situation; plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." as fluid contamination may damage internal components, the service and preventive maintenance schedule outlined in the operator's manual instructs the user to check the unit seals every six months.The operator's manual also provides the following caution statement: "immediately wipe any spills from device." there was no patient injury reported.A review of past complaints indicates that similar occurrences have been reported a total of five times since the ri-2 was placed on the market in 2015.Through our investigation, all five occurrences were traced to saline contamination as a result of improper routine or preventive maintenance.Belmont medical technologies is actively investigating to establish a root cause and have followed up with the user facility for status updates/additional information on the following occasions: 4/5/2021, 4/6/2021, 4/28/2021, 5/13/2021, 6/3/2021, 6/7/2021, 6/25/2021, 6/28/2021, 7/14/2021, 7/16/2021, 8/5/2021.Initial telephone calls on 4/5 to obtain information about the incident were followed by an in-service on 4/6 of all facilities using the ri-2.Belmont's clinical specialist subsequently hosted a zoom meeting on 4/28 with hospital nursing staff and biomed at all facilities to review prescribed routine maintenance of the ri-2 as outlined in the operator's and service manuals.Belmont technical support reached out to the user facility on 5/13 and were informed that while access to the device was not allowed, belmont would be notified of the opportunity to observe investigation of the device.On 6/3 the hospital's clinical engineering manager reported that the device may be released for investigation with belmont, however subsequent follow-ups for status updates were unsuccessful.On 6/25 belmont's sales representative became aware that his point of contact, the clinical engineering manager, is no longer with the hospital.He subsequently spoke with the manager of clinical engineering for the main campus, who reported that the ri-2 was sent to ecri for investigation.Since becoming aware on 6/25 that the device was sent to ecri, belmont has continued to follow up with the user facility (on 6/28, 7/14, 7/16, and 8/5) to determine when the device was sent to ecri, the status of the ecri investigation, and the expected completion date.An additional follow-up report will be provided as more information becomes available.

• 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
• MDR Report Key: 11772892
• MDR Text Key: 248908663
• Report Number: 1219702-2021-00058
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• 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?: No
• Date Manufacturer Received: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1