Follow up 01: h6 evaluation codes updated with information available.The available information does not reasonably suggest there was an instrument malfunction; however, it is known that thymol, a component used to make the iwash solution for the instrument, has a strong smell and exposure to it can cause adverse effects on users with sensitivity to this agent.A retrospective review of complaints was conducted going back eighteen (18) months, there have been six (6) cases related to incidents where customers have complaint about strong odor or smell coming from the iwash solution.For all the other related cases, no injury or medical intervention was reported.In addition to the review of the batch records for the iwash solution, and assessment of the instrument and the facility was done and no malfunction or non-conformance was identified.The customer was given the safety data sheets of all reagents used in the iricell system on april of 2019.Bec internal identifier: (b)(4).
|