ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number CH3581 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint of leaks on item ch3581 cannot 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 device history review (dhr) couldn't be performed due to lot number for this complaint was unknown.Medsun medwatch mandatory report uf/importer report # (b)(4).
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Event Description
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The event involved an oncology kit w/ spinning spiros, c-clip, red cap where it was reported that the device leaked.Mycophenolate leaked out between distal end of primary tubing and spiros closed system drug-transfer device (cstd).The patient had exposure to medication that leaked out onto his bedding and did not receive full dose of medication.This is a single-use device not reprocessed and reused on a patient.There was patient involvement and unknown harm reported.
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Search Alerts/Recalls
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