It was reported that a patient was administered an epidural while receiving unspecified intravenous (iv) fluids with use of a clearlink duo-vent set.It was reported 15 minutes later; the fetal heart rate (fhr) was observed to go into late decelerations.The patient was turned to the right and left side.The iv bolus continued and seven minutes later the fhr went into ¿prolonged deceleration¿.The nurse observed the iv fluid leaking onto the floor.It was reported that the iv bolus tubing was severed at the multiport site, specified as ¿broken in the middle¿.The set was changed, and a bolus of unspecified medication was administered.The patient outcome was reported as the fhr "recovered".No additional information is available.
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The device was received for evaluation.A visual inspection with the naked eye was performed and no leak, cut or slice was observed.Pressure and clear passage underwater testing were performed with no issues noted.It was observed that the male luer rigid component was cracked and a trace of external force was applied to the component, making an appearance of a white color.The sample was used, therefore, the male luer was not damaged at the beginning of treatment.The reported condition of leak was not verified.The cause of the condition could not be determined; however, a potential cause could be not conforming material and damage in the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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