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

Model Number	903-00006P
Medical Device Problem Codes	Material Separation (1562); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged incident was originally reported to belmont on (b)(6) 2024 and the initial decision was that it did not meet the criteria to be reportable.Subsequently, belmont received the user facility report from health canada on 09/18/2024 and the decision was updated to reportable, per our procedure.The internal complaint file #cmp (b)(4) has 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 disposable set involved in this incident was not returned to belmont for evaluation since it was discarded due to contamination.The user will lose the ability to infuse the patient with the affected spikes.Other spikes can be used to infuse the patient and 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.Evaluation: the spike disconnect and difficulty inserting the spike could not be verified as the disposable set was discarded and could not be sent for investigation.A precise root cause could not be identified.Possible causes of this issue include user error from gripping the tubing instead of the spike grip while removing the spike from the bag, and assembly error due to inconsistent solvent application at the spike adapter interface.We tested a retain sample from the same lot and no issues were identified.We reviewed the lot history, and no other issues were identified.The failure rate of the material in the field is low.As the disposable set was not provided, no device malfunction could be confirmed.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
It was reported that patient had blood transfusion protocol.The belmont#5 was used.During use, the white spike (that inserts into the bags) and is connected to plastic tubing became disconnected.This happened on 2 of the 3 white spike connectors on the circuit.But this was caught in time for no harm to occur.No patient harm has been reported to belmont as a result of the alleged incident.

• 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: 20478144
• Report Number: 1219702-2024-00048
• Device Sequence Number: 8266690
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown