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 08/10/2023 |
Event Type
malfunction
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Event Description
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The incident 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.It was reported that there was air in the line toward the end of infusion.The medication involved was etoposide with infusion rate of 508ml/hr.There was patient involvement and unknown patient harm reported.
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Manufacturer Narrative
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The device has been requested to be returned for evaluation; however, it has not yet been received.
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Manufacturer Narrative
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The complaint of product incorporate / allows air passage on item b30183 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 probable cause cannot be determined.The lot records were reviewed and no non conformities were found that would have led the reported complaint.
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