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BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ PLUS ANALYZER; CORONAVIRUS ANTIGEN DETECTION SYSTEM
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| Model Number 256066 |
| Device Problem
Fire (1245)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/02/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Eua # (b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while using bd veritor¿ plus analyzer it caught fire.Fire department was called, there were no injuries sustained.Eua # (b)(4).The following information was provided by the initial reporter: veritor unit that caught fire and melted.The fire dept had to be called to the facility.No reports of injuries that occurred due to this situation.Additionally, the bd sales consultant provided the following additional information: follow up call - incident occurred at approximately 6:00pm on (b)(6) 2021.While testing a patient sample, the power cable and unit became very warm.Customer noticed a fruity smell followed by burning smell, so the customer unplugged the power cord and placed the analyzer in a dry sink, shortly after, the analyzer turned into flames.Customer confirms they have been using the original power adaptor that came with the unit.
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Manufacturer Narrative
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H6: investigation summary the complaint was created for a bd veritor plus analyzer that caught on fire (ref 256066, serial number (b)(6)).It was reported a veritor¿ plus analyzer caught on fire at mercy care marion urgent care clinic in marion, ia, usa.The customer reported the bd veritor plus¿ analyzer sits at the nurses¿ station and does not get moved around.On the day of the event, (b)(6), 2021, the customer noted the analyzer was acting abnormally throughout the day.The analyzer froze and it was delayed in fully charging.The customer reported the analyzer was fully charged earlier in the day and thus, it was not connected to the power adapter when the situation occurred.In the evening, the customer powered on the analyzer and smelt a chemical smell.The analyzer was reported to be really warm and continued to get hot.The analyzer was then placed into a sink and the fire department was called.The analyzer continued to melt and there was a lot of black smoke coming from the analyzer so the customer turned on the water to prevent the fire from spreading.Around 6:51 pm local time, the event was reported to the site¿s corporate office.There was no property damage or employee injured.There was also no patient specimen impact.The clinic closed office early for safety precaution.The affected bd veritor¿ plus analyzer was returned for investigation on (b)(6), 2021.The serial number on the instrument label was not readable due to damage.Using the recovered veritor pcb serial number (b)(6), bd was able to trace to analyzer serial number (b)(6) from the device history record (dhr).The power adapter returned with the damaged instrument matched with the serial reported in the dhr ((b)(6)).The open-circuit output voltage is 5.163v.The dhr for serial number (b)(6) was reviewed and showed no discrepancy-related issues that can be correlated to this complaint.The reader passed all tests including the final assembly process, oqa, source inspection, functionality, and final packing test and manual inspection.There was extensive fire damage to the upper and lower enclosures.The battery had been completely de-soldered from the pcb.It can be pulled out of the instrument without force or tools.Visual inspection of the bottom enclosure plastic indicates the heat source was the battery cell.The battery terminals look clean and are not broken.There was still solder in the pcb holes for the battery terminals.The protective sleeve of the battery can has melted/burned away, but the material can is intact with no visible damage.The cell can has visible corrosion.This may have been caused by the water contact from the customer¿s actions.There was also soot contamination near the rear connector panel.Scorching indicates high heat existing the enclosure openings.The chassis has also melted and was fused to the outer enclosure.The melting is consistent with the right side of the battery compartment reaching the highest temperature.The pcb components above the battery has been de-soldered.It must be assumed that the battery reached elevated temperature causing the melting and the de-soldering.Soot deposits indicate flames inside all parts of the enclosure.The upper enclosure and power button had softened to come into contact with the pcb components, which were de-soldered from the board and embedded in the plastic.More soot deposits are visible.Heat damage is concentrated on the lower-right side of the pcb, the + side of the battery.This is confirmed on the underside of the board.The battery contact pads still have solder, although the battery had been de-soldered.The heat damage extends to the camera circuit, components de-soldered and camera housing melted.The coin cell has opened.The electrolytic capacitors seem to be intact without heat damage, and the venting creases are intact.The external memory ic was still present, but no readable.The cable ties holding the battery to the pcb has mostly disappeared.Only some small, burned pieces remain in the enclosure.The damage on the camera shield of the chassis is also consistent with the source of heat located near the + pole of the battery.The display is still functional when connected to a different analyzer.There was limited damage to the plastic display carrier from below, not above.The display is susceptible to esd events, so there was likely no discharge to the top of the instrument.R&d, along with a battery consult and tenergy, the cell manufacturer, investigated the returned analyzer.The disassembly details indicate that the li-ion battery cell was most likely the primary heat source.According to feedback from a li-ion battery consultant and tenergy, the following failure mechanisms that can lead to li-ion cell thermal runaway: ¿ overcharge, ¿ cathode damage due to over-discharge, ¿ overheating, ¿ external short circuit, ¿ internal short circuit caused by water ingress or manufacturing defect.It was not possible to reproduce the failure and determine a single root cause.There are three failure modes (overcharge, over-discharge, and manufacturing defect) that cannot be further discriminated.Overvoltage damage observed in field returns indicates that overcharge and cell damage due to over-discharge are possible root causes.Pcb components are damaged after the wrong power supply is plugged into the instrument.Since the failure tests were not able to reproduce the thermal runaway, internal cell damage remains a possible root cause.Capa 1937834 has 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 h10.
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Event Description
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It was reported while using bd veritor¿ plus analyzer it caught fire.Fire department was called, there were no injuries sustained.Eua # (b)(4).The following information was provided by the initial reporter: veritor unit that caught fire and melted.The fire dept had to be called to the facility.No reports of injuries that occurred due to this situation.Additionally, the bd sales consultant provided the following additional information: follow up call - incident occurred at approximately 6:00pm on (b)(6) 2021.While testing a patient sample, the power cable and unit became very warm.Customer noticed a fruity smell followed by burning smell, so the customer unplugged the power cord and placed the analyzer in a dry sink, shortly after, the analyzer turned into flames.- customer confirms they have been using the original power adaptor that came with the unit.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-apr-19.H6: investigation summary: the complaint was created for a bd veritor plus analyzer that caught on fire (ref 256066, serial number (b)(6)).On (b)(6) 2021, bd sales associate, (b)(6), reported a veritor¿ plus analyzer caught on fire at (b)(6) in (b)(6), usa.The customer reported the bd veritor plus¿ analyzer sits at the nurses¿ station and does not get moved around.On the day of the event, (b)(6) 2021, the customer noted the analyzer was acting abnormally throughout the day.The analyzer froze and it was delayed in fully charging.The customer reported the analyzer was fully charged earlier in the day and thus, it was not connected to the power adapter when the situation occurred.In the evening, the customer powered on the analyzer and smelt a chemical smell.The analyzer was reported to be really warm and continued to get hot.The analyzer was then placed into a sink and the fire department was called.The analyzer continued to melt and there was a lot of black smoke coming from the analyzer so the customer turned on the water to prevent the fire from spreading.Around 6:51 pm local time, the event was reported to the site¿s corporate office.There was no property damage or employee injured.There was also no patient specimen impact.The clinic closed office early for safety precaution.The affected bd veritor¿ plus analyzer was returned for investigation on april 19, 2021.The serial number on the instrument label was not readable due to damage.Using the recovered veritor pcb serial number (b)(6), bd was able to trace to analyzer serial number (b)(6) from the device history record (dhr).The power adapter returned with the damaged instrument matched with the serial reported in the dhr ((b)(6)).The open-circuit output voltage is 5.163v.The dhr for serial number (b)(6) was reviewed and showed no discrepancy-related issues that can be correlated to this complaint.The reader passed all tests including the final assembly process, oqa, source inspection, functionality, and final packing test and manual inspection.There was extensive fire damage to the upper and lower enclosures.The battery had been completely de-soldered from the pcb.It can be pulled out of the instrument without force or tools.Visual inspection of the bottom enclosure plastic indicates the heat source was the battery cell.The battery terminals look clean and are not broken.There was still solder in the pcb holes for the battery terminals.The protective sleeve of the battery can has melted/burned away, but the material can is intact with no visible damage.The cell can has visible corrosion.This may have been caused by the water contact from the customer¿s actions.There was also soot contamination near the rear connector panel.Scorching indicates high heat existing the enclosure openings.The chassis has also melted and was fused to the outer enclosure.The melting is consistent with the right side of the battery compartment reaching the highest temperature.The pcb components above the battery has been de-soldered.It must be assumed that the battery reached elevated temperature causing the melting and the de-soldering.Soot deposits indicate flames inside all parts of the enclosure.The upper enclosure and power button had softened to come into contact with the pcb components, which were de-soldered from the board and embedded in the plastic.More soot deposits are visible.Heat damage is concentrated on the lower-right side of the pcb, the + side of the battery.This is confirmed on the underside of the board.The battery contact pads still have solder, although the battery had been de-soldered.The heat damage extends to the camera circuit, components de-soldered and camera housing melted.The coin cell has opened.The electrolytic capacitors seem to be intact without heat damage, and the venting creases are intact.The external memory ic was still present, but no readable.The cable ties holding the battery to the pcb has mostly disappeared.Only some small, burned pieces remain in the enclosure.The damage on the camera shield of the chassis is also consistent with the source of heat located near the + pole of the battery.The display is still functional when connected to a different analyzer.There was limited damage to the plastic display carrier from below, not above.The display is susceptible to esd events, so there was likely no discharge to the top of the instrument.R&d, along with a battery consult and tenergy, the cell manufacturer, investigated the returned analyzer.The disassembly details indicate that the li-ion battery cell was most likely the primary heat source.According to feedback from a li-ion battery consultant and tenergy, the following failure mechanisms that can lead to li-ion cell thermal runaway: ¿ overcharge.¿ cathode damage due to over-discharge.¿ overheating.¿ external short circuit.¿ internal short circuit caused by water ingress or manufacturing defect.It was not possible to reproduce the failure and determine a single root cause.There are three failure modes (overcharge, over-discharge, and manufacturing defect) that cannot be further discriminated.Overvoltage damage observed in field returns indicates that overcharge and cell damage due to over-discharge are possible root causes.Pcb components are damaged after the wrong power supply is plugged into the instrument.Since the failure tests were not able to reproduce the thermal runaway, internal cell damage remains a possible root cause.A capa 1937834 has 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.
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Event Description
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It was reported while using bd veritor¿ plus analyzer it caught fire.Fire department was called, there were no injuries sustained.Eua # (b)(4).The following information was provided by the initial reporter: veritor unit that caught fire and melted.The fire dept had to be called to the facility.No reports of injuries that occurred due to this situation.Additionally, the bd sales consultant provided the following additional information: follow up call: incident occurred at approximately 6:00pm on (b)(6) 2021.While testing a patient sample, the power cable and unit became very warm.Customer noticed a fruity smell followed by burning smell, so the customer unplugged the power cord and placed the analyzer in a dry sink, shortly after, the analyzer turned into flames.Customer confirms they have been using the original power adaptor that came with the unit.
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