MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES ALLON; THERMAL REGULATING SYSTEM

Catalog Number 100-00002

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Belmont medical technologies recently became aware of an incident that reportedly occurred in the (b)(6) on (b)(6) 2021, involving post-operative mold infection.The allon has not yet been returned to belmont medical technologies for investigation.It was reported that the allon is not considered a likely source of the patient's infection.Furthermore, it was reported that the organisms discovered during water sampling of the allon were not the same as those found in the patient's clinical samples.The allon user manual provides instructions for emptying the water tank of remaining water prior to storage of the device, as well as instructions for performing a thermal disinfection process.There is also a self cleaning feature available for belmont medical technologies certified technicians.To our knowledge the patient infection is not attributed to the allon device, however we will perform a full investigation upon receipt of the unit.

Event Description

Belmont medical technologies received the following report (report number: (b)(4)) from the medicines and healthcare products regulatory agency (mhra) in the uk: equipment identified during imt into invasive post operative mould infections.The water reservoir is not accessible for cleaning.The manufacturers instructions for decontamination are not deemed safe or appropriate by ipct, h&s or medical physics.Visible mould has been observed on the retaining chain of the tank cap (this chain is immersed in the tank water during operation).Water sampling has demonstrated high numbers of both pseudomonas aeruginosa and environmental moulds (not the same organism as patient clinical samples).The imt do not consider this equipment the most likely source of patient infections, but cannot fully exclude this due to the inabiltiy to effectively decontaminate the reservoir.Form completed at request of iric.".

Manufacturer Narrative

The hospital reported that water sampling of its allon systems demonstrated high numbers of pseudomonas aeruginosa and environmental molds.Following receipt of the report, all allon systems retained by the user facility were serviced on-site by belmont medical technologies uk service department and received an annual thermal disinfection.Although the incident reportedly occurred on (b)(6) 2021, belmont did not become aware until receipt of the mhra report on may 10, 2021.Due to the length of time between the date of the incident and the report date, belmont did not have the opportunity to confirm the reported contamination.The external surface and water reservoir of the allon system should be cleaned and disinfected before each use according to the instructions provided in the user manual.As stated in the manual, "the system components maybe contaminated during use and storage of the device from numerous factors, for example: soiled hands of the user, airborne pathogens, accidental events." the manual also provides instructions for emptying the water tank of remaining water prior to storage of the device.There is an additional cleaning feature available to belmont medicaltechnologies certified technicians, which performs a thermal disinfection of the water tank and internal tubing.This thermal disinfection process is performed at every periodic maintenance.The allon should be serviced annually by a belmont medical technologies' authorized technician according to the inspection and maintenance schedule provided in the user manual.This annual service includes preventive maintenance, thermal disinfection, and filter replacement.To our knowledge the patient infection is not attributed to the allon device.It was reported that the allon is not considered a likely source of the patient's infection.The organisms discovered during water sampling were not the same as those found in the patient's clinical samples.A review of past complaints confirms that this is an isolated incident.There have been no other reports of this nature related to the allon device.Belmont will continue to monitor for similar reports of this nature.

• Brand Name: ALLON
• Type of Device: THERMAL REGULATING SYSTEM
• 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 11987946
• MDR Text Key: 267825295
• Report Number: 1219702-2021-00078
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127014
• UDI-Public: 7290012127014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 100-00002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1