Catalog Number 2N3350 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received and is currently awaiting evaluation completion.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported a non-dehp micro-volume extension set disconnected.It was further reported the patient was in the process of being transferred from the bed and the nurse observed the line was disconnected from ¿3 way manifold hep 1:1 was infusing in 50 ml syringe at rate of 1 ml/hour¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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D9 corrected information: the device was received on 24feb2021; not on 09feb2021 as previously reported.H10: a device was received for evaluation; however, it was not the reported device but a non-baxter device instead.The actual device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information for h10: based on further investigation, the most probable cause was determined to be related to the end user/methods exceeding the product pressure specifications of 45psi.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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