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

Model Number RI-2

Device Problems Material Separation (1562); Excessive Heating (4030)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser and associated disposable set were returned to belmont for investigation on december 30, 2020; the evaluation is in process.When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.No patient injury was reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.The manufacturing records for the disposable set could not be reviewed as a lot number was not available, however photographs provided confirm the report that the tubing severed between the nozzle and heat exchanger.The set involved was saved for investigation and will be evaluated.A follow-up report will be submitted upon completion of the investigation.

Event Description

Belmont medical technologies received a report from the user facility that after infusing 3 units of blood, the belmont rapid infuser, ri-2 exhibited a system error 102 (over temperature alarm) and the disposable set was severed "at the point of fluid exit coming out of the heating coil.".

Manufacturer Narrative

The rapid infuser involved in the incident was returned to belmont for investigation and was tested according to our standard operating procedures.We were unable to confirm the complaint that the unit exhibited an "over temperature" alarm, however upon receipt it was noted that the membrane switch was damaged which prevented the touch screen from functioning properly.A root cause of the damaged membrane switch could not be established.Photos of the 3-spike disposable set provided by the customer were reviewed and the upper section of the heat exchanger appears to show a blood clot, however it is difficult to draw a conclusion without investigating the set.There is not enough information about the type of infusates used during the procedure to draw a conclusion regarding the cause of blood coagulation.The only known way to cause coagulation in citrated blood is to add calcium containing products.When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.The manufacturing records for the disposable set could not be reviewed as a lot number was not available, however photographs provided confirm the report that the tubing severed between the nozzle and heat exchanger.No patient injury was reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.

• 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: 11143053
• MDR Text Key: 267824716
• Report Number: 1219702-2021-00007
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/30/2020
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1