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Catalog Number H938724 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that an unspecified quantity of em2400 valve sets came loose from the total parenteral nutrition (tpn) bags resulting in leaks.This was observed while the tpn bags were being filled.The event was further described as "tubing sprays fluids all over".There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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B3: the event occurred on an unspecified date of december 2023, further described as "over the last week".Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: the lot was manufactured between may 31, 2023 ¿ june 1, 2023.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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Search Alerts/Recalls
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