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

Model Number 3-SPIKE DISPOSABLE SET

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 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set was returned to belmont; the investigation is in process and is not yet complete.The distributor will also be contacted to determine the serial number of the rapid infuser involved, in addition to the infusates used during the procedure, as certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.Without results of the investigation, it is difficult to determine what occurred in this case.A visual inspection of the library/retain sample for this lot number was performed and there was no evidence of any defects observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All 3-spike disposable sets are 100% leak tested prior to release from belmont medical technologies.A review of past complaints indicates that there have been no additional reports of "over temperature" alarms associated with this lot number.There was no patient injury reported.A follow-up report will be submitted upon completion of the investigation.

Event Description

Belmont's distributor received a complaint from the user facility that the rapid infuser exhibited an "over temperature" alarm.

Manufacturer Narrative

The 3-spike disposable set involved in the incident was not available for investigation.The photos provided by the user facility indicate clotting in the heat exchanger and deformation of the heat exchanger ring.There is not enough information about the type of infusates used during the procedure, therefore it is difficult 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.A thorough investigation into the incident is not possible since the disposable set was not returned.Certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.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 without investigating the set, a root cause cannot be established.A visual inspection of the library/retain sample for this lot number was performed and there was no evidence of any defects observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All 3-spike disposable sets are 100% leak tested prior to release from belmont medical technologies.A review of past complaints indicates that there have been no additional reports of "over temperature" alarms associated with this lot number.It was reported that the disposable set was replaced; 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
• MDR Report Key: 10220891
• MDR Text Key: 197759090
• Report Number: 1219702-2020-00050
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)220630(10)20191106
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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 Expiration Date: 11/30/2022
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2019-11 06
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1