BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
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 a sterile repeater pump tube set leaked.A part of the spike (vent) fell out once the system was setup; liquid proceeded to leak all over.This issue was identified during setup.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, further described as "about 3 weeks ago".Initial reporter address: (b)(6).Initial reporter phone no.(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: device manufactured between september 11, 2021 to september 13, 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 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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Search Alerts/Recalls
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