MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; THERMAL INFUSION FLUID WARMER

Catalog Number	903-00006P
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint files (b)(4) and (b)(4) have been logged for this incident for traceability.The ri-2 involved in the incident has not been returned to belmont medical technologies for evaluation.The set was discarded therefore could not be sent for review.However, images were provided and the reported issue could be confirmed from the provided images.A spike disconnect is visibly obvious to the user while interacting with the set.Other spikes can be used to continue infusion.In addition, the disposable set can be exchanged to continue infusion.No patient impact was noted as a result of the reported incident.The operator's manual provides instructions on installing the disposable set and additional recommended operator actions.The step-by-step procedures in manual has warning on installing the disposable, "do not kink or twist the tubing" and "do not apply excessive pressure to the pressure transducer.The pressure transducer can be damaged with excessive force.Do not use the system if the pressure transducer is damaged".All 3- spike sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.The sets involved were discarded, therefore a thorough investigation could not be performed on the cited sets.From previous investigations, we have found the causes of the spike separation to be either an assembly issue where insufficient epoxy was applied to the spike, or a use issue where the tubing was grabbed to disconnect the spike (instead of the plastic spike itself).As the set was discarded, no device malfunction could be verified, and the root cause could not be determined.The disposable sets are 100% leak tested and visually inspected prior to sale.A retain sample from the same lot was tested and no issues were identified.The current failure rate for this issue on this lot is 0.83%.A precise root cause of the disconnect could not be determined as the disposable set was discarded.Therefore no device malfunction could be verified and the root cause could not be determined.Belmont will continue to monitor this issue moving forward.
Event or Problem Description
The user facility reported that spikes detached on two different 3-spike disposables during the same massive procedure.The spikes fell out of the blood bags, after which disposable was primed and used for administering blood since the patient was unstable, it was not fully disconnected and re-primed.However, after some time that spike fell out which was then replaced with new set of tubing.The new disposable set was primed and used for the procedure which got detached while changing the blood bag.Although the patient involved in the procedure expired, it was determined the device did not cause or contribute to the death as a new set was able to be primed and used.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 17568402
• Report Number: 1219702-2023-00042
• Device Sequence Number: 6694378
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023

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 Catalogue Number: 903-00006P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown