Additional information: the device was received for evaluation.The anticoagulant line was connected to the check valve.The female connector of the anticoagulant line was found to be broken, which would lead to a leak.The female connector is made of polyethylene terephthalate glycol (petg).The reported condition was verified.The cause of the condition was a compatibility issue between the device and flolan ph12, a glaxosmithkline (gsk) product.Gsk has issued hpra safety notice (b)(4) to the uk markets indicating that ¿flolan solution prepared with sterile diluent (ph12) must not be used with any preparation or administration materials containing polyethylene terephthalate (pet) or polyethylene terephthalate glycol (petg).¿ per the safety notice, use of flolan ph12 with pet or petg components can lead to leaks due to cracking or damage.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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