Device malfunction [device malfunction]; pseudosepsis reaction [pseudosepsis].Case narrative: this case is cross-referenced with the case ids (b)(4) (cluster).Initial unsolicited serious device case was received from united states on (b)(6) 2017 from a physician.This case concerns a patient (demographics not reported) who developed pseudosepsis reaction on the same day after receiving treatment with synvisc one.Device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient-initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml (batch/lot number: 7rsl021 and expiration date: 31-may-2020; device malfunction reported) for osteoarthritis.The same day, the patient had pseudosepsis reaction to synvisc one.Corrective treatment: not reported for both the events.Outcome: unknown for both the events.Seriousness criteria: medically significant for device malfunction.A product technical complaint (ptc) was initiated for synvisc one, batch number:7rsl021 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.
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