BAXTER HEALTHCARE CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A hemodialysis patient using a gambro cartridge dn prime line, experience an external blood leakage at the pump tubing during infusion.The blood loss was reported to be less than 150ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there was no deviation found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation.The cause of the failure was not determined.Eight retained samples from the same lot were visually inspected.No deviations or damages were observed during the inspection of the retained samples.Under water leak testing was performed on the eight retained samples with no anomalies observed.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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