BAXTER HEALTHCARE CORPORATION CLEARLINK PACLITAXEL SETS; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2R8858 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Device manufacturer address 1: (b)(6).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 a clearlink, paclitaxel set presented an air alarm.This was observed during unspecified process step.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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Additional information was added to h6 and h10.H10: the device was not returned and the lot number is unknown; 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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