Investigation of this complaint found that processing of tissue samples in both the "daily surgical protoocl" protocol started in retort a at 11:17am on 22 march 2018; and the "biopsy 2hr" protocol started in retort b at 16:04pm on 22 march 2018 was delayed because an error code indicating that the condensate bottle was not in contact with the corresponding sensor resulted in pausing of both protocols.At 07:17am on 22 march 2018, the following information was displayed to the user, "please empty the condensate bottle".The root cause of the sub-optimal tissue processing reported by the complainant was the intermittent occurrence of event code "13 - condensate bottle is not present, insert bottle to continue." this resulted in the "daily surgical protocol" being paused approximately 942 times between 18:39 on 22 march 2018 and 03:02 am on (b)(4) 2018.The root cause of the condensate bottle moving out of contact is the corresponding sensor cannot be unequivocally determined from the information available.This has in turn resulted in retort a being left empty, after completion of 4 of 13 steps of the protocol, between 20:12 on 22 march 2018 and 03:02 am on (b)(4) 2018 which would have contributed to the sub-optimal tissue processing reported by the complainant.Although the "daily surgical protocol" protocol started in retort a at 11:17 am on 22 march 2018 subsequently continued through steps 5 to 7, these were carried-out between 03:02 am and 03:09 am on 23 march 2018 at a reduced duration in an attempt to meet the end time calculated by the software scheduler (approximately 09:44 pm on 22 march 2018).A user subsequently abandoned the protocol at 03:10 am on (b)(4) 2018, after the completion of 7 out of 13 protocol steps (final dehydrant).Details of the regimen used to continue processing of the 193 samples from the abandoned protocol are not available.
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On (b)(4) 2018, leica biosystems received a complaint that both runs in retorts a and b had failed overnight; and during the processing runs the condensate bottle was not recognized.The complainant advised that the processing runs on retort b stopped in formalin step and retort a stopped in the final alcohol step; and described the tissue as "overhydrated "fried" some tissue unuable".On 27 march 2018, leica biosystems (b)(4) received information from the applications specialist that "two cases are still under review".On 28 march 2018, leica biosystems (b)(4) received the following information from the laboratory "there are actually three cases now.Recuts did not help with the last one.One was re-collected (additional skin taken) and two were sent out for expert analysis.Diagnoses are pending." no further information was provided to leica biosystems despite several requests being made to the laboratory.On 09 april 2018 a leica field service engineer (fse) attended the site to investigate the reported condensate bottle "not being recognized"; and documented that condensate bottle was functioning as expected, that the instrument was functioning to specifications, that customer is ensuring that the condensate bottle is fully inserted in the instrument and no further instances of condensate bottle not being detected have occurred.
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