MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Model Number	903-00006P
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Emits Odor (1425); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is pertaining to the 2nd disposable set involved in the incident.The internal complaint file (b)(4) has been logged for this incident for traceability.The user facility confirmed that the disposable set involved in the incident will be sent to belmont for review but we haven't received it as of (b)(6) 2024.The user facility reported leak from tubing that was too hot to touch when they opened the chamber."belmont tubing ruptured with blood leaking from the housing and an electrical smell.When i removed the tubing from the pump the ring was very hot." after a couple of units, blood started leaking/pouring from the belmont onto the floor.We opened the door to the belmont to try and see where the leak was occurring.It was hard to visualize and from what we could tell it was due to a defect in the tubing.Again, due to the situation we immediately switched to the 3rd belmont.There is no report of any patient harm associated with this incident.Upon further follow-up with the user facility, it was confirmed that platelets and cryoprecipitate were infused during this event using the rapid infuser.The operator's manual contains information on contraindicated fluids and clearly states that "platelets are contraindicated for use with the system and should not be used", as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger may become overheated.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.In order to avoid similar incidents in future, belmont offered refresher training for clinical staff at the user facility to familiarize them with compatible solutions and proper use of device per our specifications, but it was declined.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The user facility reported the following: we had two reports incidents of belmont malfunction.One in the ed and one in the or with leaking tubing and too hot to touch when they opened the chamber."belmont tubing ruptured with blood leaking from the housing and an electrical smell.When i removed the tubing from the pump the ring was very hot." "i later learned that there was similar incident in the ed with belmont tubing rupturing.".
Additional Manufacturer Narrative
The device was requested for investigation multiple times, however it was not sent to belmont for investigation.Belmont contacted the user facility on september 11th, september 25th and october 23rd requesting the return of the device for investigation and obtain additional information however it was not provided.The disposable set involved in the incident was requested but was not provided for investigation.A thorough investigation into the disposable set involved could not be carried out.All disposable sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies no further issues were reported on the rapid infusers involved in the incident.No device malfunction could be verified and the root cause could not be determined.The complaint file will be reopened in the event the device or additional information become available.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: 3-SPIKE DISPOSABLE SET
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• 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: 20410652
• Report Number: 1219702-2024-00046
• Device Sequence Number: 7983812
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 903-00006P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown