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

Model Number RI-2

Device Problem Sparking (2595)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has been returned to belmont for evaluation.Evaluation of the unit is in process; a follow-up report will be submitted.The manufacturing records for this serial number were reviewed and nothing notable was observed.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." the manual also provides the following warning statement: "to avoid risk of electric shock, this device must only be connected to a supply main with protective earth" and instructs the user to "ensure that circuit breaker is easily accessible to turn off in an emergency situation." it was reported that the unit was not in use on a patient at the time of the incident, and that there was no injury to the staff.A follow-up report will be submitted upon completion of the investigation.

Event Description

The biomed at the user facility reported that when the rapid infuser was plugged into the ac outlet, there was a spark at the back of the unit and it has been unable to power up since.

Manufacturer Narrative

The rapid infuser was returned for investigation and was tested using our standard operating procedures.Upon receipt, four power transistors on the driver boards were shorted and damaged, which prevented the unit from powering up.A definitive root cause of the damaged power transistors cannot be established.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." the manual also provides the following warning statement: "to avoid risk of electric shock, this device must only be connected to a supply main with protective earth" and instructs the user to "ensure that circuit breaker is easily accessible to turn off in an emergency situation." the manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that the unit was not in use on a patient at the time of the incident, and that there was no injury to the staff.A review of complaints for the past three years indicates that this was an isolated incident.We will continue to monitor and trend similar reports of this nature and take further corrective action if required.Should additional information become available, a supplemental report will be submitted.

• 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: 9856948
• MDR Text Key: 195116354
• Report Number: 1219702-2020-00030
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1