The event involved a customer allegation regarding a transpac iv monitoring kit with safe set reservoir stating that during infusion the pressure line was disconnected/broken between the line and the blood withdrawn port.The device was replaced with no further problems encountered.There was patient involvement, however, there was no adverse event and no delay in critical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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One (1) used partial set 01c-42640-06 transpac® iv monitoring kit with safeset; reported lot# 3514084 was received for testing.Testing found a tubing separation in the 27" arterial pressure tubing and the safeset port.Sufficient solvent was applied to the bond.In comparison of the tubing end to a sample where the tubing that pulled out of the tubing pocket, and the tubing that was received separated, it appears the same amount of solvent was present on both.A device history review (dhr) was completed and no relevant non-conformities were noted.The reported complaint of tubing separation was confirmed.The cause of the separation appears to be due to excessive pulling force near the safeset port.
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