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

Model Number	903-00018P
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure with an acutely bleeding trauma patient, an accidental incident occurred with a 3l reservoir.Where the return hose is connected to the reservoir, the weld broke in the middle of the transfusion, and the blood started gushing out over the rapid infuser.This happened after the trauma staff had been working for about 45 minutes with the rapid infuser.The belmont's distributor confirmed on (b)(6) 2022, that there was no patient injury as a result of the reported incident.
Additional Manufacturer Narrative
The internal complaint file#: (b)(4) has been logged for this incident for traceability.The ri-2 and disposable involved in the incident has been obtained by the distributor but has not yet been returned/ received by belmont medical technologies for evaluation.The user reported that during a procedure with an acutely bleeding trauma patient, an accidental incident occurred with a 3l reservoir.Where the return hose is connected to the reservoir, the weld broke in the middle of the transfusion, and the blood started gushing out over the rapid infuser.This happened after the trauma staff had been working for about 45 minutes with the rapid infuser.The distributor confirmed on (b)(6) 2022, that there was no patient injury as a result of the reported incident.Belmont have followed up on october 26th, october 28th and november 9th to obtain additional information but have not yet received any further information on the 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 disposable sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.Review of complaints confirms that this is an isolated incident.Belmont is waiting to get the device back for investigation.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Additional Manufacturer Narrative
The impacted sample has not been returned to belmont for inspection.A review of the pictures provided by the distributor indicate that a separation occurred where the hose is connected to the reservoir.It is not possible to determine if the root cause of the separation was a handling issue or a manufacturing issue from the pictures provided.A review of the manufacturing records and retain sample indicate no issues for this lot and no other similar complaints have been received for this lot.Belmont confirmed that there was no patient injury as a result of the reported incident.This is regarded as an isolated incident and belmont shall continue to monitor for any similar incidents.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: PUMP, INFUSION
• 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: 15849476
• Report Number: 1219702-2022-00042
• Device Sequence Number: 12341709
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: 00896128002008
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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 Model Number: 903-00018P
• Device Catalogue Number: 903-00018P
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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