| Catalog Number D139702 |
| Device Problems
Fire (1245); Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/19/2023 |
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Event Type
malfunction
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Manufacturer Narrative
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Per fda request, mdr submissions for the ngen pump are to be reported with procode and common device details of the catheter used along with the ngen pump.However, no catheter information was provided.Follow-up is being performed.The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a ngen pump and a fire issue occurred.It was reported that saline solution got on the ngen pump ac adapter and the ac adapter caught on fire.The ngen console to pump cable was "fried," due to the fire, and there was black residue all over the cable.The ac adapter was replaced, the ngen console to pump cable was replaced, and the saline drip was moved away from the power cables.The procedure continued.The ngen components have been removed from use at this time.Additional information was received on 19-dec-2023.There was a fire in the lab.The fire flared up after the first application, originating from the ngen pump's power supply, which was soaked with saline from a spilled saline bag.The procedure was finished.There was no impact on the patient.There was no issue with ngen pump and trupulse generator.Both were workable after they changed the power supply cable which was burned.The saline leaked from the bag and the liquid was on top of the power cable of ngen pump.That liquid met with an electric current and caused fire.They could not check the saline bag and tubing set because those were burned.It was thought the potential leakage sites were the connection sites between the saline bag and tubing set chamber or the tubing set itself if it was damaged.The leurs / connections between the pump/tubing/saline bag fit correctly.It was not actively leaking after they extinguished the fire.Does not know if it was leaking when the incident happened.However, could confirm after the incident was the fire came from the ac adaptor of ngen pump and it was wet with saline.They could continue the procedure after they changed the ac adaptor, tubing, and the saline bag.They confirmed every connection and no leakage before they resumed the procedure.The hospital safety manager took the damaged cable.Additional information was received 22-dec-2023.No damage/issue/failure on the carto 3 system due to the fire.No sign of visible fire or flame.No excessive amount of heat during use.No part of the equipment melting/carbonized.There was a spark near the ngen pump but not near the carto 3 system.Biomed took the ngen cables and wants the ngen pump looked at.There may be damage to the ngen pump power adapter since the spark was in the same outlet it was plugged into.
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 17-jan-2024, noted a correction to the 3500a initial.The following statement under h10.Additional manufacturer narrative does not apply to this system and therefore was added in error: "per fda request, mdr submissions for the ngen pump are to be reported with procode and common device details of the catheter used along with the ngen pump.However, no catheter information was provided.Follow-up is being performed." note: the information submitted under fields d2a.Common device name and d2b.Procode under the 3500a initial were completed correctly.
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Manufacturer Narrative
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In the 3500a initial, the tubing set was reported as an ¿unknown tubing set¿ under the ¿d10.Concomitant medical products and therapy dates¿ section.Additional information was received on 05-feb-2024 stating the tubing set was the ngen pump tubing.However, does not have the specific tubing product information.States, it was probably a biosense webster, inc.Product and would verify.Due to the additional information provided on 05-feb-2024, the device was added to the complaint file as a bwi ¿unk_smartablate pump tubing¿ and the assessment was made to also report this event under this bwi device.The awareness date for this device is 05-feb-2024.Therefore, biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00191 for product code d139702 (ngen pump).(2) mfr # 2029046-2024-00681 for product code unk_smartablate pump tubing (smartablate¿ irrigation tubing set).Also updated the d10.Concomitant medical products and therapy dates¿ section from ¿unknown tubing set¿ to ¿ unk_smartablate pump tubing¿.In addition, information was received on 06-feb-2024.Room was cleaned.Unsure if the equipment was cleaned prior to use or what solution it was cleaned with.There was no residue solution of isopropyl alcohol or other flammable solution in the area.They observed the fire about 30 minutes in, at first application of energy.Saline solution was in the iv bag.The trupulse remote sits in the white tray that was reflecting in the picture prior to the fire.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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Additional information was received on 29-feb-2024.There was no issue with the tubing set.The problem was the bad setup between the saline bag and the tubing.This was a personal error from the account personnel.The adaptor was not provided by biosense webster, inc.It was pulled from another generator in the hospital.This account has about 5 of them.The leak was caused by the inappropriate set up of the saline bag and the tubing set and not by faulty products.The damaged ac adapter was recovered by the biomed at the hospital.The generator was checked and it was working properly with the adapter that was pulled from the other generator.No new adapter was requested by the account as the physician believes it is not bwi's fault but theirs as they were prepping in a rush.It was also indicated that ¿fire¿ was not the best word to describe the issue as there was only a spark, meaning a short circuit after saline dropped over the adapter.Therefore, added under h 6.Medical device problem code ¿improper or incorrect procedure or method ((b)(6))¿.The investigation was completed on (b)(6)2024.It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a ngen pump and a fire / spark issue occurred.It was reported that saline solution got on the ngen pump ac adapter and the ac adapter caught on fire.The ngen console to pump cable was "fried," due to the fire, and there was black residue all over the cable.The ac adapter was replaced, the ngen console to pump cable was replaced, and the saline drip was moved away from the power cables.The procedure continued.The ngen components have been removed from use at this time.According to additional information, there was no issue with the tubing set, the problem was the bad setup between the saline bag and the tubing.This was a personal error from the account personnel.The leak was caused by the inappropriate setup of the saline bag and the tubing set and not by faulty products.The damaged cable was replaced.The event may have occurred due to a user error.According to the instructions for use (ifu): to prevent electric shock and fires, connect the pump to a grounded main outlet that meets the specifications, and do not expose the pump to excessive humidity.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: appropriate term/code not available (g07002) were selected as related to the reported ¿user error¿ issue.-investigation findings: operational problem identified (c13)/ investigation conclusions: cause traced to component failure (d02) / component code: cable, electrical (g02004) were selected as related to the customer¿s reported ¿fire/spark¿ and ¿cable¿ issues.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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