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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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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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 six of eight.
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Manufacturer Narrative
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A video was provided by the customer.There was leakage observed from the vent plug juncture with the cap open.The person in the video wiped the fluid below the vent plug juncture and there was fluid observed on the plum pump as well.The operator stated that when the cap is closed there is no leakage.The reported complaint of leakage on the 14001-31 primary plum set can be confirmed with the cap open.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 8075764 was reviewed and no non-conformities were found that would have led to the reported complaint.
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Search Alerts/Recalls
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