ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/; STOPCOCK, I.V. SET
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Catalog Number B30183 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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One used device was received, connected with spiros was received for evaluation, along with a used bd phaseal and a fresenius kabi 0.9% sodium chloride injection usp freeflex 250 ml intravenous bag was also returned for evaluation.The inlet filter appeared to be wetted out.No additional damage or anomaly was observed.The set was primed and purged as per procedure, only a leaks coming from the inlet filter vent was confirmed, no leaks from the bd phaseal connection were confirmed, neither air in line after purge the lines.No air in line were identified after the test.However complaint of leaks can be confirmed based on the physical sample evaluation.The probable cause is typical due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.A device history review was conducted and no non conformities were found that would have led the reported complaint.
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Event Description
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The event involved a 32" (81 cm) appx 6.3 ml, 15 drop admin set w/0.2 micron filter, rotating luer w/filter cap, bag hanger which had air in line observed towards end of taxol infusion at the rate of 182ml/hr.There was patient involvement; harm was not reported as consequence of this event.
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