The event involved a customer allegation regarding a transpac iv monitoring kit stating that approximately one hour into infusion the pressure line was disconnected/broken from the safeset blood withdrawing port.The device was replaced with no further problems encountered.There was patient involvement, however, there was no adverse event and no delay in critical therapy.The device was used with a phillips monitor for blood pressure monitoring and heparinized saline medication.
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Icu medical testing facility received one (1) used partial set, list # 01c-42640-06, transpac iv monitoring kit with safeset; reported lot # 3514084.As received, a tubing separation was observed between the 27" arterial pressure tubing and the safeset port.The probable cause of the tubing separation was insufficient solvent applied to the bond.The reported complaint of tubing breakage or separation was confirmed.A review of lot# 3514084 showed 3500 units were manufactured, tested, and inspected and released october 2017.There were no non-conformities noted.
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