Model Number PELORIS II |
Device Problem
Application Program Problem: Parameter Calculation Error (1449)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the information provided, the tissue samples exhibiting sub-optimal tissue processing are derived from the "12 hr - autopsy" protocol comprising 82 cassettes, which started in retort a at 12:58pm on (b)(6) 2019 and failed at 22:28pm on (b)(6) 2019 during step 10 (final clearing step) of the protocol.Investigation of this complaint found that processing of tissue samples in "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 was delayed because the condensate bottle was not in contact with the corresponding sensor for approximately seven (7) hours between 15:21pm and 22:28pm on (b)(6) 2019, which resulted in pausing of the protocol.The tissue samples in retort a remained covered with 94.2% ethanol from bottle 10 until the connection between the condensate bottle and the corresponding sensor was re-established at 22:17pm on (b)(6) 2019.Steps 5 to 10 of the "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 were executed between 22:18pm and 22:28pm on (b)(6) 2019 at a reduced duration, in an attempt to meet the end time calculated by the software scheduler.The reduced duration of these processing steps did not allow sufficient time to adequately heat the retort manifold for wax transfer resulting in failure of "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019.Details of the regimen used to complete processing of these tissue samples was not provided.The root cause of the sub-optimal tissue processing reported by the complainant was that steps 5-10 of the "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 were executed between 22:18pm and 22:28pm on (b)(6) 2019 with a markedly reduced duration, in order to meet the end time calculated by the software scheduler, when the protocol paused for approximately seven (7) hours because the condensate bottle had moved out of contact with the corresponding sensor.The root cause of the condensate bottle moving out of contact with the corresponding sensor could not be unequivocally determined from the information available.
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Event Description
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Leica biosystems received a complaint of "over processed tissue", which occurred on "sunday night" following completion of processing.The complainant advised that four (4) blocks were affected; and tissue processed in wax on the same instrument.On 03 january 2020, the leica senior applications specialist-core histology received the following information from the complainant: "these tissues were dry to the point of falling off the slides during staining.Customer then retrieved additional tissue from their autopsy storage and processed those tissues in place of the original samples.They were able to diagnose these new samples." on 09 january 2020, leica biosystems (b)(4) received further information from the leica senior applications specialist-core histology that: "it turns out that this was a prostatectomy the decided to run on their autopsy run and not autopsy tissue.All of the prostate gland was submitted, but only partially grossed.So, they pulled from that sample and diagnosed from that.However, they said they are waiting for more info to determine whether the margins will have any impact on further patient care.".
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Search Alerts/Recalls
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