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

Model Number	FMS 2000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon further discussion with the user facility, it has been determined that the catheter in use at the time of the event was a 7fr triple lumen 20cm, which is an 18g catheter and is not compatible with a rapid infuser flow rate set to 500ml/min.The operator's manual provides a chart to help guide the user to select an appropriate cannula size for the decided flow rate.When infusing prbcs with an 18g cannula, as reported by the user facility, the maximum flow rate should not exceed 100ml/min.It was reported that the flow rate was set to 500ml/min at the time of the event, in which case the 18g cannula would restrict the output of the rapid infuser and result in a "high pressure" alarm.Although the rapid infuser has not been returned to belmont for investigation, the manufacturing records for this serial number were reviewed and nothing notable was indicated; the unit has not been returned to belmont for service since it was shipped to the customer in 2015.The actual disposable set was not returned for investigation, but the manufacturing records of the associated lot were reviewed and no anomalies were identified.We have contacted the user facility again for additional details about the case and the status of the patient.We will also offer to provide further in-service training for the clinical staff and remind the user facility of the instructions for use in the manual.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
Belmont's clinical specialist received a complaint involving a belmont rapid infuser and reported the following: the rapid infuser was being used on a patient in the icu and 2 units of blood were infused at 45-60ml/min.The flow rate was set to 500ml/min and kept alarming.The flow rate was decreased and while infusing the third unit of blood the unit began exhibiting a "high pressure" alarm and stopped.They switched to another pump and begain infusing blood at 999ml/hr (approximately 15ml/min).The nurse stated that the triple lumen they were using was rated by the manufacturer for 10ml/hr and no other line was used.Further discussion with the customer determined that the catheter being used at the time of the event was a 7fr 3 lumen 20cm.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 8250342
• Report Number: 1219702-2019-00004
• Device Sequence Number: 16533443
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1