MAUDE Adverse Event Report: BIOMÉRIEUX INC. INCUBATOR MOD RGHT W/RACKS 3D

Model Number 210161

Device Problems Fire (1245); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: the bact/alert¿ 3d low temperature (lt) module is part of the bact/alert¿ 3d dual-t system, which is an automated microbial detection test system capable of incubating, agitating, and continuously monitoring aerobic and anaerobic culture media.The laboratory is responsible for validating the bact/alert¿ 3d dual-t system and culture bottles for their testing purposes.Description of the problem a customer in (b)(6) notified biom¿rieux of overheating at the power input and a start of fire in association with incubator mod rght w/racks 3d (ref.210161, serial number (b)(4) ) which is part of bact/alert¿ system.The customer reported that the equipment presented overheating at the power input and there was a start of fire that was extinguished by the operators with a fire extinguisher.Biom¿rieuxs customer service reported that this happened only on the incubator module and the issue was solved by replacing the power entry ref.805-0017-02.The incubator is connected to a smart ups apc 1500.The power cord was unplugged immediately and the customer used a fire extinguisher.It has been reported that there were no patient/user harm nor injury.Following repair by biom¿rieux field service engineer, the instrument was verified as working correctly.There is no indication or report from the customer that this event led to any adverse event related to any patient's nor user state of health.An investigation will be initiated.

Manufacturer Narrative

Complaint investigation was initiated in response to one complaint relating to a short circuit and fire on a bact/alert® 3d incubation module (im) serial number (b)(6), part number 210161.The clinical hospital is located in argentina.The fire occurred at the power entry module (pem) on the back of the instrument where the power cord connects the instrument to the customer facility power, and was put out by the customer with a fire extinguisher.The complaint was determined to be a reportable event in the united states.No injuries were reported.The field service engineer (fse) replaced the power entry module (pem) part 805-0017-02, and returned unit back to service.The customer site has reported previous power outages and issues with other laboratory equipment.Global customer service (gcs) requested the im be replaced.The same im had a previous complaint from the customer for power loss in july 2021, there was no burning, the fuses were checked, and the system was operational.The root cause of the issue for this complaint investigation could not be determined because the im and damaged parts were not returned for the investigation.The investigation was extended to allow more time for the return, but had to be closed as no parts have been received.There was no specific impact to a patient reported, the laboratory staff can handle the bottles manually when the instrument is down.The impact to the customer is that they must use extra resources to perform the manual handling of the blood cultures, in performing gram stains and subcultures.There is a potential for harm to the laboratory staff if the instrument fire is not contained, or someone is burned or harmed trying to extinguish it.The instrument pem is designed to smoke to allow detection of an overheating situation by voltage.The instrument design prevents an overvoltage from traveling (fuses, metal oxide varistor).Failure to provide sufficient information and return of parts prevents the investigation from making accurate conclusions that relate to the products and/or instruments.Root cause could not be determined because the instrument and damaged parts were not returned to the manufacturing site for further evaluation.An applicable risk assessment was unable to be performed without evaluation of the damaged instrument parts.In the event that additional information/ parts are received from the field service engineer (fse) and/or the customer, the risk assessment can be revised.The fse confirmed the appropriate 5 amp fuses were in use.Pictures of the im from the customer's site show that the pem plastic was burned, the fuses were intact, and the metal oxide varistor was intact, indicating no overvoltage traveled inside the instrument.The customer has the im connected to a ups (uninterruptible power supply) and the fse stated this ups showed no errors and was operational.The pictures do show the environment was dusty.Global customer service (gcs) recommends periodic cleaning to remove accumulated dust around the instrument.The im's serial number indicates the instrument was originally built in may 2008.The immediate action by the customer was to use a fire extinguisher to put out the fire, and then to contact the biomérieux field service engineer for the repair.The immediate action by the local field service engineer was to replace the instrument¿s power entry module (pem) and it was determined the instrument was working correctly.There was no specific harm or injury stated in the complaint record.No adverse trend was identified by the investigator in the complaint or manufacturing data for bact/alert 3d systems and smoking or burning power entry modules.When an instrument is down, all blood culture bottles are considered negative to date until the gram stain and subculture grow an organism.If the customer has room, they can move the bottles to another functioning incubation module connected to the same control module.When more than one (1) hour of instrument readings are missed for any reason, an error 80 will flag indicating the gap in bottle readings, and the user manual states to perform gram stains and subcultures for those bottles.The customer must take appropriate back up actions to handle the culture bottles manually in the event an instrument goes down and they cannot be relocated within the same instrument system.Gcs recommends that the customer have a down-time procedure in place for their laboratory.The customer indicated their electrical engineer will evaluate the circuitry in the laboratory.The customer has each im connected to a ups already, as a precaution for their facility power issues.The electrical engineer should assess that these ups and ims are connected appropriately.If the requested parts are received, a new investigation will be created to evaluate them at that time.

• Brand Name: INCUBATOR MOD RGHT W/RACKS 3D
• Type of Device: INCUBATOR MOD RGHT W/RACKS 3D
• Manufacturer (Section D): BIOMÉRIEUX INC.; 595, anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 12533385
• MDR Text Key: 273358721
• Report Number: 1950204-2021-00076
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026049591
• UDI-Public: 03573026049591
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K903505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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 Model Number: 210161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1