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

Catalog 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	06/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint file (b)(4) has been logged for this incident for traceability.Belmont received a report for this incident on june 26th, 2024.The ri-2 involved in the incident was returned to belmont medical technologies (uk) office and the user confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.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.The cited disposable set was discarded and could not be sent for investigation.The lot number was unknown so an investigation into the lot history could not be performed.All disposable set are 100% leak tested and visually inspected prior to release.The rapid infuser involved was evaluated by a belmont service technician (uk).All sensors were cleaned and checked with no issues.The device underwent a full system test and passed with no issues.No device malfunction could be verified, and the root cause of the alleged leak could not be determined.Belmont will continue to monitor this type of incident closely and take further corrective and preventive actions if required.
Event or Problem Description
It was reported that while administering a major haemorrhage protocol (mhp), 2 bags of blood were successfully transfused and the set-up looked okay.However, when transfusing the third bag of blood it was noted that blood was leaking through the door? the reporter was uncertain of the source of the leakage, but a slight gaping was observed on the door.The initial device was replaced and the replacement device used with the same protocol administered as per plan and patient need.No patient health impact or consequence was reported.

• Brand Name: 3-SPIKE DISPOSABLE SET
• Common Device Name: PUMP, INFUSION
• 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: 19811684
• Report Number: 1219702-2024-00034
• Device Sequence Number: 12636630
• Product Code: FRN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Catalogue Number: 903-00006P
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/23/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown