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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 coolflow® irrigation pump was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Requested for clarification on the account/facility to this complaint.However, no further information has been made available.If additional information is received regarding this account/facility, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
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Attention: officer (b)(4).Date: (b)(6)2019.Subject: response to fda request for report# 2029046-2018-01935 fda follow up letter dated:(b)(6)2019.Manufacturer reference number: (b)(4).Product description: coolflow® irrigation pump this is a response to the fda¿s letter dated (b)(6)2019 regarding a report of a product malfunction: it was reported that a patient underwent an ablation procedure with a coolflow® irrigation pump.After the pump was turned on and bubbles were noted to be in the tubing, the bubble sensor failed to alarm.There were no patient consequences.The bubble sensor failed to detect the air bubbles and therefore, this event was assessed as a reportable malfunction.1.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: (1) an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual (2) a complete description of investigation and analysis methodology(ies) used, (3) an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and (4) any conclusions reached based on the investigation and analysis results.Response: (1) an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual response: the device was sent to the shanghai maintenance center for testing and it was found that the bubble sensor was not working properly.The bubble sensor was replaced with a new sensor and the issue was resolved.(2) a complete description of investigation and analysis methodology(ies) used: response: information regarding the coolflow® irrigation pump was reviewed.The coolflow® irrigation pump with serial number (b)(4).Device history record was reviewed and verified that the pump was manufactured in accordance with documented specification and procedures.After the complaint was logged, the device was sent to the shanghai maintenance center for testing.The device was evaluated, and it was confirmed that the bubble sensor was defective.The defective bubble sensor was replaced.The device was also subjected to preventive maintenance, safety and functional testing, and all tests passed.The coolflow® irrigation pump instructions for use (ifu) states under preventative maintenance, ¿it is recommended that periodic inspections be performed annually.¿ preventative maintenance can be performed by the customer.However, all units that come for repair receive preventative maintenance.The last preventative maintenance done by biosense webster before the event was performed on (b)(6)2016 and then again on (b)(6)2018 as part of this complaint investigation.(3) an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved response: the bubble sensor of the device failed.When a defective part is identified, the part is replaced, and the device is tested for passing specifications and preventative maintenance is performed.(4) any conclusions reached based on the investigation and analysis results.Response: the analysis from the shanghai maintenance center was reviewed, and it was identified that the bubble sensor was defective.Defective bubble sensor contributed to undetected bubbles in the tubing.2.What actions has your firm taken to address this problem? response: this device is at the end of life and is no longer being manufactured or sold as of (b)(6)2015.Therefore, no further actions will be taken for this device.In addition, complaint trends are monitored monthly, and no significant trends have been identified at this time related to the undetected air bubbles for the coolflow pump.3.Please provide the results of risk management activities completed by your firm which address the reported device problem.Indicate the frequency and severity of the hazard, cause(s), and the applicable control(s) implemented to mitigate the hazard.Response: design failure mode and effect analysis (dfmea) for the coolflow® irrigation pump identifies a potential design failure mode of ¿erroneous indication: says no bubble when bubble present¿ as having a potential harm of ¿air embolism¿ with a severity of 5 (severe) and an occurrence of 1 (improbable), as the worst-case scenario.This occurrence/severity combination have an acceptable residual risk of as far as possible (afap).The risk control activities are captured within the dfmea and include redundant bubble sensors; software checks both detectors and shuts down if not in agreement; tests during manufacturing; power-on and periodic self-test.The complaint evaluation, of the pump bubble sensor failure to alarm, concluded that the reason of the failure was due to a defective bubble sensor and when the defective part was replaced, the issue was resolved.The overall complaint rate for 2 years (december 2016 ¿ november 2018) of a defective bubble sensor was 0.025% and overall complaint rate for 2 years of the undetected bubble reported by customer was (b)(4).However, the occurrence of the harm is 0.The ifu states when loading the tubing set ¿open the stopcock and fill the tubing set with irrigation fluid.Remove any trapped air and then close the stopcock.¿ in addition, when preparing the pump for irrigation, ¿if you see any air in the tubing, hold down on the flush button until the air is expelled through the open end of the tubing¿.4.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same problem/issue.Please identify how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that your firm has received in the past 2 years that are related to this same reported device problem.Response: this complaint is the only complaint received and mdr that has been submitted in the last 2 years for undetected air bubble for the coolflow® irrigation pump.5.Please provide the total number of devices manufactured, distributed and, if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside the us.Response: this device is no longer being manufactured.Therefore, there have been no new devices manufactured or sold after (b)(6)2015.We are unable to provide the devices used per year, however, we can provide the amount of tubing set sales for the past three years.To use the pump a tubing set must be used.Per the ifu, ¿the tubing set is intended for single use only¿.Tubing set sales: product family -> year -> sales coolflow tubing set -> 2016 -> 204313 coolflow tubing set -> 2017 -> 170358 coolflow tubing set -> 2018 -> 125258 coolflow tubing set -> 2019 -> 9241 *please note 2019 is through february 18 product complaint #
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> (b)(4).
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