BAXTER HEALTHCARE CORPORATION DUO-VENT CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2R8875 |
Device Problems
Filling Problem (1233); 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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Event Description
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It was reported that an unspecified quantity of clearlink system, solution sets had difficulty infusing unspecified chemotherapy drug and/or saline with a 999 ml/hr flow rate; the infusions took longer.This event was identified during patient use.The infusion rate tested between 700 ml/hr to 900 ml/hr.The pump displayed a downstream occlusion alarm.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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This event occurred during (b)(6) 2022, further described as in the "past three days".(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual devices were not available; however, a companion sample was received for evaluation.Visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.A functional testing was performed including clear passage and pressure testing; and the results were satisfactory.Additional priming was performed and no defect was observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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