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 Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A used list #b33902, 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer (lot #unknown) was returned from the customer for investigation.Tpn/lipids solution residuals were observed in the device and the filter was separated from the tubing.No additional damage or abnormally were observed.No mating device was returned.No solvent was present in the return device.The complaint of disconnection/loose connection can be confirmed based or the physical sample evaluation.The probable cause was due to insufficient solvent applied during manual assembly process in manufacturing.A device history record (dhr) review could not be conducted because a lot number was not identified.
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Event Description
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The event occurred on an unspecified date and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer.It was reported the tubing (containing tpn and lipids) disconnected from the filter which compromised the line of the premature neonate infant in a level 3 nicu.As a result, especially because the neonate had an underdeveloped immune system, the patient required a complete blood count (cbc) and c-reactive protein (crp) test/check for two days in a row as part of a sepsis laboratory test panel.The crp results for the patient were elevated and the cbc results were within normal limits.Further clinical impact to the patient as a result of this event is yet to be determined.Besides blood tests, just more clinical monitoring has been required.This is the third of four occurrences.No additional information is available at this time.
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