BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2H8519 |
Device Problem
Reflux within Device (1522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).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 blood backflow was observed while using two (2) clearlink system continu-flo solution sets.At the start of the infusion on an infusion pump, blood return was observed.The clinician verified that the catheter position was correct and then changed the alleged set with a new set.Again, the blood return was observed while using the second set.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Device manufactured between: september 26, 2018 to september 27, 2018.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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