Model Number PB-NC5302 |
Device Problem
Material Deformation (2976)
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Patient Problem
Therapeutic Response, Increased (2272)
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Event Date 03/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: medrad pressure infusion equipment; therapy date (b)(6) 2018.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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The customer reported that while performing a cta of the pulmonary arteries with a non-bd power injector it pressured out at 4ml/second while injecting isovue 370 (which ranges from 80ml-100ml based on patient weight and procedure) along with a 25ml ns flush.The slide clamp on the tubing caused the tubing to remain crimped after it was released, which prevented a full dose of the medication from being delivered.This caused the patient to receive additional medication to complete the procedure, and an additional ct scan.There was no lasting harm.
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Manufacturer Narrative
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The customer¿s report of a crimp in the tubing was confirmed but was determined to be unrelated to the power injection issue.The report of increased pressure (restricted flow) was confirmed.Visual inspection showed a kink/crimp in the tubing approximately 6.5mm from the male luer.Functional testing showed that the high pressure is due to an incompatibility between the concomitant non-bd pressure injector syringe and tubing and the neutraclear valve.The male luers of the non-bd syringe and pressure injector tubing have a section with an internal diameter of 1.35mm.The neutraclear directions for use state that the neutraclear needle-free connector is compatible with iso 594 certified luers with an internal diameter larger than 1.5mm.The concomitant device male luer is incompatible and caused restricted flow through the neutraclear.The kink/crimp in the tubing due to the engagement of the slide clamp is normal and does not lead to a loss of flow or a rise in pressure.The root cause of the restricted flow is an incompatibility between the neutraclear connector and the male luers of the mating products.
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Search Alerts/Recalls
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