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 Problem
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 to be returned for evaluation; however, it has not yet been received.Additional contact information: biochem polska s.A.(b)(6).
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Event Description
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The event involved a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave¿, luer check valve on an unknown date in (b)(6)2023.The reported issue was blocking of the infusion sets during the process of administering doxorubicyna during cytostatic infusion.The set was connected to infusomat space cyto-sets braun- to 3 (three) different types.Problems occurred on the beginning: when the nurse started to administer medicines there was immediate blocking.There was no patient harm reported, however there was patient involvement and delay in therapy.This is the second of four reports.
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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 record 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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