Model Number 11448964 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
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Event Description
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It was reported tubing disconnecting at the hub when normal saline was pushed through.There was no report of patient impact, delay or serious injury.
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Event Description
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It was reported tubing disconnected at the hub and attached to one used 500ml baxter bag, vancomycin 1.5g added to 0.9% sodium chloride injection.There was no report of patient impact, delay or serious injury.
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Manufacturer Narrative
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Correction to sections d.1, d.4, and g.5.Cont¿d from d.11: 100ml baxter bag, lot: p396879, exp: sep21, 5% dextrose injection-curos cap attached to each smartsite; 500ml baxter bag, lot: y307884, exp: aug20, vancomycin 1.5g added to 0.9% sodium chloride injection, lot: v1 5 110519, exp: 02/03/2020 -curos cap attached to distal smartsite.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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Manufacturer Narrative
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The customer¿s report that the tubing disconnected was confirmed.The set was received with a separation at the engagement between the drip chamber and tubing components.Inspection of the separated tubing end observed insufficient to no solvent traces and evidence that the tubing was not fully inserted into the outlet spigot of the drip chamber.Dimensional analysis of the separated tubing was observed to be within specification.The root cause is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.
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Event Description
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It was reported tubing disconnected at the hub and attached to one used 500ml baxter bag, vancomycin 1.5g added to 0.9% sodium chloride injection.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
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Search Alerts/Recalls
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