Catalog Number ASKU |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 that during continuous renal replacement therapy using a prismaflex set, the access line became disconnected from the vascular access when moving the patient.Air entered the access line and could not be removed by the operator.The treatment was terminated without returning the extracorporeal blood to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The 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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Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
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Search Alerts/Recalls
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