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

Model Number	903-00006P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file #(b)(4) has been logged for this incident for traceability.The disposable set involved in the incident was returned to belmont for evaluation on (b)(6) 2023.Although the patient involved in the incident died, there is no allegation that the device contributed to death.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.Testing of the returned device is ongoing (although not complete) and no leak in the disposable set has been found.There is no information about the lot number of the device to allow the review of device manufacturing records.Belmont is currently investigating the returned disposable.Without results of the device investigation, no final conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Event or Problem Description
The distributor reported that the disposable leaked during a case.No lot# is available but the set was saved and will be sent back for investigation.The patient reportedly expired in this event but, it was stated by the distributor that the death was not attributed to the reported issue with the disposable set.
Additional Manufacturer Narrative
The cited disposable was returned to belmont medical technologies for evaluation on may 18th 2023.Upon receipt of the referenced disposable, the service engineers were unable to find any issues through visual inspection.The disposable set was extensively tested under high pressure for an extended period of time, however no leak from the set could be verified.From the image provided, blood was seen on the right side of the device at, and under the roller pump.A possible cause of this blood in the device is a loose or disconnected recirc line which could have been interpreted as a leak.The lot number was unknown, so no further investigation could be performed on the lot.All 3-spike sets are 100% visually inspected and leak tested prior to shipment.The disposable set was replaced to resolve the issue.Belmont will continue to monitor this issue going forward.

• 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
• 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: 17140082
• Report Number: 1219702-2023-00029
• Device Sequence Number: 14945365
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: Lay User/Patient
• Device Model Number: 903-00006P
• Device Catalogue Number: 903-00006P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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