(b)(4) no iabp part was returned to teleflex chelmsford for investigation.The customer provided a video for evaluation.The video shows artifacting on the arterial pressure and picked up at significantly higher heart rate, which created the excessive triggering consistent with the event details.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.The reported complaint of "arterial pressure has artifact and is being picked up at significantly higher rate that actual heart rate and creating excessive triggering" is confirmed based on the video provided in the complaint.The video shows artifacting on the arterial pressure and picked up at significantly higher heart rate, which created the excessive triggering consistent with the event details.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the abnormal ap trigger.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
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