ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET
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Catalog Number B33902 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Event Description
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The incident involved a 13'' (33 cm) smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer.The customer reported that the filter was disconnectioning and leaking during infusion.He said that the disconnect was to the hard plastic of the filter like adhesive wasn¿t there.The medication involved were total parenteral nutrition (tpn) and lipids.There was no harm reported, but they drew complete blood count and monitored protein for the patient.This is the second of five reports.
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Manufacturer Narrative
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One (1) used sample list #b33902 (out of five reported issues) and several photos were returned for evaluation, as received it was confirmed that the tube came separated from filters.No additional damage or abnormally were observed.No mating device was returned.After visual inspection, there was no solvent presence in the tube, either in the filter.A photo was shared by customer, where is observed a filter separation from tube.In the photo, the separation is observed from the filter section.The complaint of disconnection / loose connection can be confirmed based on the review.The probable cause was due to insufficient solvent applied during manual assembly process in ensenada.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.
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Search Alerts/Recalls
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