Hospital pharmacy has started using chemo clave closed system transfer device products (spinning spiros) for pharmacy and rn safety w/ chemotherapy preparation and admin.We have had several problems w/ various parts of these systems from icu medical inc: leaking, breaking, falling off the syringe, etc.We have reported each to the mfr via the icu medical rep.I reported a malfunction with the spinning spiros which occurred to mfr.Fludarabine iv syringe and tacrolimus ivpb prepared for multiple different pt and delivered to unit.Rn had just begun setup, but did not begin any infusion, and came to pharmacist w/ broken spinning spiros (cracked at seam) or fallen off the syringe or fallen off the tubing even after tech and pharmacists have double checked they were secured prior to delivery.These closed systems are supposed to aid w/ safety and decrease risk of exposure to hazardous medications.However, when the leak, crack and break or fall off when about to infuse, they are putting associates and event pt at risk.Fda safety report id# (b)(4).
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