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

Model Number	903-00006P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the following: we had two reports incidents of belmont malfunction.One in the ed giving error message and one in the or with leaking tubing and too hot to touch when they opened the chamber.The user facility reported that the first belmont after a couple units (i cannot remember the exact amount) gave an error message.We switched to another pre-primed belmont and started transfusing."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." no patient impact was reported as a result of this incident."i later learned that there was similar incident in the ed with belmont tubing rupturing.".
Additional Manufacturer Narrative
This report is pertaining to the 1st 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 that the first belmont after a couple units (i cannot remember the exact amount) gave an error message.We switched to another pre-primed belmont and started transfusing.No patient impact was reported as a result of 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.Belmont was unable to confirm if the device provided an overheat alarm.If an alarm is provided, 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.Other methods can be used to infuse the patient.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.All disposable sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete.Note: a separate report (#1219702-2024-00046) will be submitted by belmont for the 2nd device involved in this incident.
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: 20410457
• Report Number: 1219702-2024-00045
• Device Sequence Number: 15714386
• 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