Catalog Number ASKU |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/13/2019 |
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 a filter clotted alarm was generated by the prismaflex control unit during treatment.The patient was performing continuous veno-venous hemodiafiltration using a prismaflex control unit and a prismaflex set.The customer stated that the filter was dark.The patient was disconnected without blood return.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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The device was not returned and the serial number remains 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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Search Alerts/Recalls
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