Sakura finetek europe provided investigation for this incident.The investigation shows that the customer tried to start a run while the mandatory cleaning between runs was not done yet.As "start" was selected, we assume there were samples inside the retort.Upon not being able to start the run, the user took out the samples again, leaving a certain volume of eosin enriched formalin inside the retort that subsequently was purged in paraffin container 14 when starting the cleaning run.The run after the cleaning run was the affected run reported by the customer.Reagents were analyzed and showed no abnormal signs, except for the formalin smell and eosin seen in paraffin container 14.This contamination has been found to be the rootcause of the incident.From technical point of view there is no sign of a system failure that could have cause the incident, the pressures, positive and negative are in range, the timings are correct, and the temperatures are as expected.On 15-mar-2024, the customer communicated the following numbers concerning patient impact: total number of blocs saved after another run or technically usable: 191.Total number of blocs lost : 21.Total number of cases impacted by lost blocs : 9.
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Sakura finetek europe notified sakura finetek usa on 22-feb-2024 that on 15-feb-2024, the french application specialist was made aware of an incident with the tissue-tek vip® 6 vacuum infiltration processor at a french customer.Customer was processing a run overnight which ended normally, but when the customer opened the retort of the instrument in the morning, customer smelled formalin.All samples in that run (204 biopsies) have been affected, but the impact on the patients is currently unclear.Customer found formalin contamination in the last paraffin container.
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