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It was reported while using the bd veritor plus analyzer, the analyzer caught fire and smoke was detected from the lab area of the pediatric clinic.No team members nor patients were present at the time.Team members obtained a fire extinguisher, alerted emergency services, and extinguished the fire.One team member with a history of asthma was taken to the emergency department, given a breathing treatment, and discharged home.Mw5108719.
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It was reported while using the bd veritor plus analyzer, the analyzer caught fire and smoke was detected from the lab area of the pediatric clinic.No team members nor patients were present at the time.Team members obtained a fire extinguisher, alerted emergency services, and extinguished the fire.One team member with a history of asthma was taken to the emergency department, given a breathing treatment, and discharged home.Mw5108719.
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The complaint was created for a bd veritor plus analyzer that caught on fire (p/n 256066, serial number (b)(6).Customer reported via medwatch mw5108719 that smoke was detected from the lab area of the pediatric clinic where no team members nor patients were present at the time.A bd veritor plus analyzer that tests for rapid flu and contained a lithium battery caught fire.The device history record for bd veritor plus analyzer, sn (b)(6), was examined and showed no discrepancies related to this issue that can be correlated to this complaint.The reader passed all the tests including the final assembly process, oqa, source inspection, functionality, final packing test and manual inspection.The veritor plus risk file was reviewed (see baltrm-256066-ha, rev 19.0, id 87.1, s2).Bd quality will continue to monitor for trends related to the veritor system.The analyzer with sn (b)(6) was returned for investigation.The instrument shows extensive heat damage preventing disassembly.The extend of the damage prevent any disassembly.The upper enclosure has melted and burned completely around the display area, leaving only small remnants around the module slot.The display has been severely damaged and only pieces were returned separately from the instrument.The display frame has melted to the main pcb and is partially burned.The burned enclosure also reveals that the chassis under the main pcb melted and burned.The real time clock battery has opened.The large electrolytic capacitors have been desoldered from the pcb and are embedded in melted plastic of the chassis.The bottom enclosure has melted and burned around the trigger board connectors.The plastic body of the dc input connector has melted or burned revealing the metal connector parts.The bottom of the instrument shows extensive heat damage.Parts of the support surface have been embedded in the melted plastic.The thermal damage is more prominent on the right side of the instrument, consistent with hot gases escaping from the battery + terminal.The module cover shows soot deposits indicating that hot gases escaped through the module compartment.Significant deposits around the battery cell prevent any further analysis.The power supply had been connected to the analyzer at the time of the incident, but was disconnected when the parts arrived at bd.It is the bd power supply.It is still operational and the output voltage is 5.168 v.The insulation around the barrel connector has melted burned, exposing the wires.The damage to the plastic parts and main circuit board are consistent with thermal runaway of the li-ion cell.On 21 april 2022, bd associates (including quality & engineering) visited prisma health greenville, sc in response to a reported fire originating with a veritor analyzer.The incident happened in a children's clinic, a non-hospital and non-laboratory environment.The following observation were made.- in the room, the cabinet where the veritor had failed had been removed.The arrangement of instruments or any additional equipment could not be confirmed.- there were 2 instruments reported to have been collocated with the veritor analyzer: o hemacue glucose 201; 12 v dc power input barrel connector.O accuvein; 5 v dc power input barrel connector.- the accuvein instrument uses a charging cradle that stays in place while the instrument is used with patients.- the hemacue instrument is used like veritor, in place or mobile.- there was a 3rd instrument, siemens clinitek urine analyzer.It uses 9 v dc input barrel connector.Only during our questions, it was confirmed that it also sat on the same cabinet as the veritor.- the second lab using the veritor was significantly smaller and more space constraint.- the veritor was located on a rack where it could not be used.It would have had to be moved to insert a cartridge.- the power strip was 4/5 filled with other ac cables.- another siemens clinitek was connected to this power strip.- the veritor was not connected per the new safety protocol.- in that lab, the same assortment of instruments was present, but distributed differently based on available ac outlets.- the staff reported that ~60 % of veritor tests are performed in walk-away mode (requiring dc input).Based on the storage scheme, the analyzer would need to be moved into position to use.Disconnection and reconnection of the power input is very much possible in this process.Emergency department - the emergency department poc staging room was also visited.- aside from several instruments, 2 pcs were located on the counter.- there were multiple power strips distributed on the counter, and 90 % filled.- aside from 2 veritor power supplies, we observed 24 v and 12 v supplies, both with barrel connectors.- the personnel indicated that 90 % of tests were performed in walk-away mode, but only one analyzer was present in the room during our visit.The extend of the damage prevent any disassembly, thus the root cause of failure cannot be determined.A capa have been initiated to address the power issue failures.Based on the results of this investigation, the issue cited in the complaint is confirmed.Bd quality will continue to monitor for trends related to this failure.H3 other text : see h.10.
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