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

Model Number	903-00006P
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 uk for review but they haven't received it yet.Belmont has confirmed that the issue was identified prior to any use on a patient and that no patient or user injury resulted due to the alleged incident.A review of previous complaints was conducted on the lot in question detailing a complaint rate of 0.167% no patient impact was reported as a result of this 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.Belmont confirmed that the user saved the disposable in question and has requested the return of the set for investigation.Belmont uk is working with the user facility to get the disposable involved in the incident and investigate it.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.
Event or Problem Description
Belmont received mir reference number (b)(4) on (b)(6) 2024 which detailed the following: during priming of set, water leaked out of the one-way check valve.Set removed from use and replaced.New set working correctly.Note that the mir incorrectly detailed the lot number involved as (b)(6) 2012.The lot number involved was subsequently confirmed as (b)(6) 2021.
Additional Manufacturer Narrative
The disposable set involved was reviewed by engineering.The reported leak from the air vent could be confirmed.After further inspection, it was found there was a hole in the center of the hydrophobic membrane of the air vent which led to the reported leak.The root cause is consistent with a potential assembly error.Subsequent to the disposable being manufactured in 2021, belmont has, via our continuous improvement process, improved the assembly process of the air vent of the 3-spike disposable set to reduce the potential occurrence of leaks.The current complaint rate for this incident type is low, at (b)(4).We will continue to monitor these incidents going forward.

• 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: 20422921
• Report Number: 1219702-2024-00047
• Device Sequence Number: 20942619
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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
• Device Lot Number: 2021-12-04
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/06/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown