ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK; STOPCOCK, I.V. SET
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Catalog Number 011-H1225 |
Device Problem
No Flow (2991)
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Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available for evaluation, however has not been received.E1 facility name: specialistic hospital in brzozów ¿ podkarpacki oncology center.
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Event Description
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The event occurred on an unspecified date in (b)(6)2023 and involved a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave¿, luer check valve.The reported issue was blocking of infusion sets during process of administering irinotecan.011-h1225 was connected to infusomat space cyto-sets b-braun- to 3 (three) different types.Problems occurred at the beginning when the nurse started to administer medication (immediate blocking).There was no serious injury or blood loss.There was unprotected chemo exposure and patient involvement, however no report of patient harm.This captures four of four occurrences.
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Manufacturer Narrative
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The complaint of no flow / can't prime / difficult to prime on item 011-h1225 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 12733917 was reviewed and no non conformities were found that would have led to the reported complaint.
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Search Alerts/Recalls
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