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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR

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LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR Back to Search Results
Model Number PELORIS
Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2016
Event Type  Malfunction  
Event Description

Leica biosystems received a complaint regarding failure to drain the cleaning alcohol. Information reported by leica field service engineer (fse) suggests that a use error involving failure to complete the reagent replacement processing in accordance with the manufacturer instructions may have been involved in this event. Investigation of this complaint by leica biosystems is in progress.

 
Manufacturer Narrative

Manufacturer evaluation of the instrument logs did not identify any instance involving failure to drain the cleaning alcohol on (b)(6) 2016, as reported by the complainant. However, two (2) instances indicating insufficient reagent in bottle 6 (80/20 ethanol/ipa) and one (1) instance indicating insufficient wax in wax chamber 1 were recorded in the instrument logs on 14 december 2016. The instrument functioned as designed in each of these instances by substituting the bottle or wax chamber containing insufficient reagent with reagent or wax from a suitable alternative station. There are 687 instances in which an event code indicating insufficient reagent has been recorded in the instrument logs in the period between (b)(6) 2016; and there are 243 instances indicating that a bottle containing either a processing or cleaning reagent was not in contact with the corresponding sensor for less than 20 seconds, which is not sufficient time to complete manual replacement of the reagent; and the properties of the corresponding reagent station were reset in the period between (b)(6) 2016. Resetting a reagent station sets the concentration to the default value configured in the reagent types definition unless an alternative value is entered into the instrument software by the user; and resets the number of cassettes processed and the number of cycles and days to zero. The root cause of these events being recorded in the instrument logs are use errors involving failure to follow the manufacturer instructions related to both the fill level required for reagent bottles and wax chambers as detailed in section 2. 2. 2 of the leica peloris/peloris ll user manual and the manual reagent replacement procedure as detailed in section 5. 4. 4 of the leica peloris/peloris ll user manual. Although the complainant did not report any adverse impact on the quality of tissue processing, it is considered that the malfunction involving incorrect completion of the manual reagent replacement process would either cause or contribute to a serious injury upon recurrence because this use error has previously caused serious injury.

 
Event Description

There was no report of any adverse impact on the quality of tissue processing from the complainant in relation to this complaint.

 
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Brand NamePELORIS RAPID TISSUE PROCESSOR
Type of DeviceAUTOMATED TISSUE PROCESSOR
Manufacturer (Section D)
LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
495 blackburn road
mount waverley, victoria 3149
AS 3149
Manufacturer (Section G)
LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
495 blackburn road
mount waverley, victoria 3149
AS 3149
Manufacturer Contact
adrienne hardisty
495 blackburn road
mount waverley, victoria 3149
AS   3149
92117535
MDR Report Key6248399
MDR Text Key65079562
Report Number8020030-2017-00005
Device Sequence Number1
Product Code IEO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberPELORIS
Device Catalogue Number26.0005
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/24/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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