ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT; STOPCOCK, I.V. SET
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Catalog Number B33276 |
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 03/01/2024 |
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 that a 6" smallbore trifuse ext set w/3 microclave®, 0.2 micron filter, 3 clamps, rotating luer generated a leak during patient infusion.It was reported that the total parental nutrition (tpn) filter was leaking and sticky upon initial assessment.The issue was noticed on the 4th day of using the trifuse infusing tpn and was due for a line change in the next few hours.There was a patient involved and no harm was reported.
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