Catalog Number H938724 |
Device Problems
Fluid/Blood Leak (1250); Component Missing (2306)
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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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The event occurred on an unspecified date of (b)(6) 2022, further described as "two weeks ago".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 em2400 valve set leaked after the device was set-up.One of the valves had a missing piece (valve core).There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The event occurred on an unspecified date of (b)(6) 2022, further described as "two weeks ago".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 em2400 valve set leaked after the device was set-up.One of the valves had a missing piece (valve core).There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added to d9, h3, h4, h6 and h10.H4: the lot was manufactured from november 26, 2020 ¿ november 30, 2020.Correction to f10/h6: health effect ¿ impact codes: from f26 to f27.H10: the device was received for evaluation.Visual inspection was performed which observed that the valve core of port 2 was missing.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to assembly issue during the manufacturing process.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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Search Alerts/Recalls
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