Catalog Number UNK_PRD_00341 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (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 treatment with a revaclear dialyzer, an external blood leak out of the plastic section of the arterial connection of the dialyzer was observed.Approximately 350 ml of blood loss was recorded.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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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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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Corrected information h6: fda code b14 is no longer applicable.A batch review was not performed.This was inadvertently populated.H10: the device was not returned and the lot number is unknown; therefore, a device analysis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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Search Alerts/Recalls
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