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 Date 10/04/2021 |
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 the tubing of a sterile repeater pump tube set leaked.The event was further described as tubing leak and found that the pvc tubing was completely detached from the blue wing connector.This issues was identified during testing prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Lot # 60303121.Expiration date.05/31/2024.Unique identifier (udi)#: (b)(4).Device manufactured between june 23, 2021 to june 24, 2021.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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