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

Model Number RI-2

Device Problems Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was received for evaluation on (b)(6) 2020.The investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.We have contacted the user facility to obtain additional information about the case, including the type of infusate used during the procedure, as well as information about the disposable set.When the rapid infuser recognizes a situation that may compromise safe and effective infusion, 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.It was reported that there was no injury to the patient.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

The user facility reported that the rapid infuser exhibited an "over temperature" alarm (system error #102).

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation.Upon receipt, the input temperature probe sensor was dirty, which caused the unit to exhibit an "over temperature" alarm as reported.The temperature probes should be cleaned before or after each use according to the service and preventive maintenance schedule provided in the operator's manual, as dirty, wet, or blocked temperature probes can cause the rapid infuser to exhibit an "over temperature" alarm.The routine maintenance instructions in the operator's manual state: "keep the probe sensors clean and dry.If they become dirty or wet, clean with a moistened q-tip and dry.Use care not to damage the sensor surface." 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 this serial number were reviewed and no anomalies were identified.It was reported that there was no injury to the patient.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 01821
• MDR Report Key: 9678559
• MDR Text Key: 190147288
• Report Number: 1219702-2020-00012
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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: 903-00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1