Root cause: the samples returned by the customer were tested and no air bubbles or leaks were found.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that an end user could not remove air bubbles from two high pressure lines from the same lot number.The patient reportedly died, but the end user stated the patient's death was not caused by the high pressure lines.The defective samples were returned to the manufacturing facility where they were analyzed.The samples were purged with a bleach/water solution and then placed in a batch of bleach/water solution overnight.The lines were then cleaned and dried for visual inspection, which they paced.The tapers on the connectors were verified and met specification.Using a hydrostatic tester, the lines were pressurized to 200psi and checked for signs of leakage.No leaks were seen.The lines were pressured to 600psi for 10 seconds and 1,000psi for 10 seconds with no failures.One line was taken and pressurized until it burst.No leakage was seen and the line burst at 1,080psi.Customer complaints were reviewed for similar reports.No similar reports were identified.From january 3, 2017 to january 9, 2019, deroyal has sold (b)(4) cases or (b)(4) each.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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