ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 14001-31 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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It was reported, on an unknown date in november, a primary plum set transparent disposable generated a leak during usage in a patient.When initiating the infusion, it was noted that the set was dripping/leaking.It was not reported that the set was contaminated, presented any biological risk, or contained any chemotherapeutic agent and that medicines were used with the set.The set was not reprocessed or re-sterilized.There was a delay in therapy, however, no one was harmed, and was not reported that an adverse event occurred as a result of this event.This is report five of eight.
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Manufacturer Narrative
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Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
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Search Alerts/Recalls
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