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 08/07/2023 |
Event Type
malfunction
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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.It was reproted that air was noted in filter mid way.The event occurred on (b)(6) 2023, and the medication involved is enhurtu, with infusion rate of 118 ml/hr.There was patient involvement and no harm was reported.
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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.
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Manufacturer Narrative
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The complaint of filter allows air to pass 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.A device lot history was reviewed and no non conformities were found that would have led the reported complaint.
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