BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
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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 the unspecified quantity of sterile repeater pump tube sets leaked.During compounding, "the connection of the filter does not attach properly and falls during use" and the hose leaked.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Event date/concomitant medical products: the event occurred (b)(6) 2022.Initial reporter address: (b)(6).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 from october 26, 2021 - october 28, 2021.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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