Catalog Number 955595 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 an external fluid leak was observed on a prismaflex m100 set c during priming due to an unspecified damage.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed that the return screwed connector was broken.The reported condition was verified.The cause was transportation related.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/07/2021.
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Search Alerts/Recalls
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