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Model Number 10014914 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: spinning spiros closed male luer, red cap, syringe tubing, phaseal, 35ml monoject syringe, saline flush syringe.No product will be returned per customer.The customer complaint of visible air in syringe tubing during a doxorubicin infusion could not be confirmed due to the product was not returned for failure investigation.The attached photo received does not represent the actual event sample for this (b)(4).The photo does not confirm visible air in the syringe tubing.
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Event Description
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It was reported that for a 90 minute doxorubicin 25ml infusion, the nurse manually primed the syringe tubing with a normal saline flush syringe, massaged the pressure sensing disc to remove any air, clamped the tubing, and attached the 35ml syringe that had a closed system drug transfer device (cstd) at the end; afterward there was a visible column of air in the line extending from the pressure sensing disc to the proximal end of the tubing.The doxorubicin is prepared "on-site" and is hand carried down one floor and is at room temperature prior to the infusion.The customer states there was no patient harm.
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Search Alerts/Recalls
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