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
Break (1069); 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 06/01/2023 |
Event Type
malfunction
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Event Description
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The event occurred on from late (b)(6) and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer, where it was reported that their nicu had experienced malfunctions in the last 3 weeks related to a broken filter.The stated issue was product disconnecting/falling apart.There was leaking and the defective product was infusing with fluid, total parenteral nutrition (tpn) and lipids.There were several patients involved, no patient harm but patients needed septic work ups, and there was delay in therapy as all tubing had to be changed delaying administration.This captures one of twenty occurrences.
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Manufacturer Narrative
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It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
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Manufacturer Narrative
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One used sample item #b33902 was returned for evaluation, as received the outlet filter was separated from the rest of the device.No presence of solvent in the tube, neither in the filter port through ultra violet (uv) light were observed.No additional damage or anomalies were observed along the set.Complaint of filter separation can be confirmed based on the physical used sample evaluation.The probable cause was due to an insufficient solvent applied during manual process assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Device returned to manufacturer on 8/7/2023.
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