Model Number 2432-0007 |
Device Problems
Stretched (1601); Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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The customer reported on the neuroscience/neurosurgery unit, the rn primed the set with solumedrol 1000mg/200ml.When the infusion was started, the line was noted to be occluded.The rn noted the set had crystalized sediment on the tubing and a "balloon".There was no patient harm, and the set was changed.
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Event Description
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It was reported that the clinician primed the set with solumedrol 1000mg/200ml on the neuro unit, however noted obstruction in the tubing upon starting the infusion.While troubleshooting, the nurse identified crystalized sediment on the tubing as well as ballooning on the pump segment of the tubing.The pharmacist was notified, and the set was changed.There was no patient harm.
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Manufacturer Narrative
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The customer report that the set had crystalized sediment on the tubing and the pump segment had ballooned was confirmed.Visual inspection of the as-received sample immediately observed a bulge/balloon in the silicone segment p/n (b)(4) in the area directly below the upper fitment component, as well as sediment throughout the set.During functional testing it was observed that the fluid would not flow through and exit the set as expected.The root cause of the customer's report could not be determined.
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Search Alerts/Recalls
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