MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-19 for PELORIS RAPID TISSUE PROCESSOR PELORIS II 26.0008 manufactured by Leica Biosystems Melbourne Pty. Ltd.
[136604903]
Manufacturer evaluation of the instrument logs provided showed that bottle 9 (ethanol) was not in contact with the corresponding sensor for approximately nine (9) minutes and 40 seconds at 09:48am on (b)(6) 2019, which is sufficient time to replace the reagent; and the station properties were reset at 09:57am on (b)(6) 2019. A user manually set the concentration to 100% in the instrument software at 09:57am on (b)(6) 2019. Bottle 9 (ethanol) was not in contact with the corresponding sensor for approximately 45 seconds, which is insufficient time to replace the reagent; and the station properties were reset at 10:00am on (b)(6) 2019. A user manually set the concentration to 100% in the instrument software at 10:00am on (b)(6) 2019. Based on the information provided, the tissue samples exhibiting sub-optimal tissue processing are derived from the "factory 2hr xylene standard" protocol comprising one (1) cassette, which started in retort a at 11:30am on (b)(6) 2019 and completed at 13:40pm on (b)(6) 2019; and the "factory 8hr xylene standard" protocol comprising 142 cassettes, which started in retort b at 16:37pm on (b)(6) 2019 and completed at 08:30am on (b)(6) 2019. Although a user manually set the ethanol concentration in bottle 9 to 100% in the instrument software at 09:57am and 10:00am on (b)(6) 2019, the discrepancy between the measured ethanol concentration of 70% and that calculated by the instrument software of 99% indicates that a use error occurred during replacement of this reagent. As the instrument software uses reagent concentration to select reagent stations when a protocol is scheduled, the reagent station with the lowest (in-threshold) concentration of a reagent group or type is selected for the first step using that reagent group or type; and reagent stations of increasing concentration are used for the succeeding processing steps of the reagent group or type. Reagent with the highest concentration is always used for the final processing step of a reagent group or type before changing to another reagent group or type. As a consequence, the reagent in bottle 9 (ethanol) was used for the final dehydration step of the "factory 2hr xylene standard" protocol started in retort a at 11:30am on (b)(6) 2019; and the "factory 8hr xylene standard" protocol comprising started in retort b at 16:37pm on (b)(6) 2019, from which sub-optimal tissue processing was identified. The root cause of the sub-optimal tissue processing reported was a use error, which occurred between 09:48am and 10:00am on (b)(6) 2019, as evidenced by the discrepancy between the measured and calculated ethanol concentration in bottle 9. The facts suggest that a user failed to correctly complete manual replacement of the reagent in bottle 9 (ethanol) as detailed in the leica peloris/peloris ll user manual. The leica peloris/peloris ll user manual contains the following specific warning: "always change reagents when prompted. Always update station details correctly - never update the details without replacing the reagent. Failure to follow these directives can lead to tissue damage or loss. "
Patient Sequence No: 1, Text Type: N, H10
[136604904]
Leica biosystems received a complaint that approximately 140 blocks were "over process/brittle/hard", following processing. The complainant advised that "bigger cases are mostly brittle"; and the processing run(s) ran to completion with no error codes displayed. On 21 january 2019, a leica applications specialist (fss) provided telephone support in order to obtain further information regarding the circumstances involved in this complaint and to provide applications support. The fss was advised that the measured ethanol concentration for bottle 9 was 70% and the calculated concentration by the instrument software was 99%. The fss was also advised that "a staff member, inadvertently, selected "yes" when prompted to use the default setting (contents in the bottle were 70% ethanol and not 100% ethanol)". The complainant replaced all the reagent bottles designated for xylene and all four wax baths; and scheduled to complete user training on (b)(6) 2019. On 25 january 2019, the leica applications specialist received information that: "1 case was completely not diagnosable, one case was incompletely diagnosed (ihc would not stay on)"; and that re-biopsy has been recommended and performed for the (b)(6) years old female patient. This information was documented in the adverse event information form, which was received by leica biosystems (b)(4) on 28 january 2019. On 30 january 2019, the leica applications specialist received clarification from the laboratory that the "one case incompletely diagnosed (ihc would not stay on)", was able to be diagnosed. This information was received by leica biosystems (b)(4) on 31 january 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020030-2019-00004 |
| MDR Report Key | 8352613 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2010-09-10 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ADRIENNE HARDISTY |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3149 |
| Manufacturer G1 | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 3149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELORIS RAPID TISSUE PROCESSOR |
| Generic Name | AUTOMATED TISSUE PROCESSOR |
| Product Code | IEO |
| Date Received | 2019-02-19 |
| Model Number | PELORIS II |
| Catalog Number | 26.0008 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Address | 495 BLACKBURN ROAD MOUNT WAVERLEY, VIC 3149 AS 3149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-19 |