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

Model Number PELORIS II

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

Leica biosystems rec'd a complaint regarding sub-optimal processing of tissue in approximately 200 cassettes, which comprised colon, skin and prostate samples, from multiple processing runs.The complainant described the affected tissue samples as "limp and mushy"; and advised that the affected tissue samples had been re-processed.On (b)(4) 2015, leica biosystems rec'd information that all tissue samples exhibiting sub-optimal tissue processing were diagnosable.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Bottle 4 ((b)(4) ethanol) was removed from the instrument for three (3) minutes at 18:38pm on (b)(6) 2015 and bottle 5 (ethanol) was removed from the instrument software for approximately seven (7) minutes at 18:42pm on (b)(6) 2015, which is sufficient time to complete manual replacement of the reagent; and the properties of the corresponding reagent station were reset.Resetting the reagent station set the concentration to the default value configured in the reagent types definitions ((b)(4) in this instance); and reset the number of cassettes processed and the number of cycles and days to zero.Information provided by the laboratory indicates that prior to commencement of the processing protocols from which sub-optimal tissue processing was reported, a user had replaced the reagent in bottle 4 ((b)(4) ethanol) with (b)(4) ethanol and set to the default value of (b)(4) and bottle 5 (ethanol) with (b)(4) ethanol and set to the default value of (b)(4) in error.Bottle 4 ((b)(4) ethanol) which contain (b)(4) ethanol was used in the first dehydration step and bottle 5 (ethanol) which contain (b)(4) ethanol was used in the final dehydration step of the protocols, from which sub-optimal tissue processing was reported.The minimum final reagent concentration required for ethanol is (b)(4).The consequences of using ethanol at a concentration less than the minimum required for the final dehydration step in a protocol is re-introduction of water into the tissue which cannot be displaced in subsequent processing steps; and contamination of reagents used in subsequent processing steps ultimately resulting in sub-optimal processing.The root cause for the sub-optimal tissue processing reported was a use error, which occurred during the replacement of ethanol in bottles 4 and 5 completed prior to commencement of the protocols from which sub-optimal tissue processing was reported.

Event Description

On (b)(6) 2015, a leica field support specialist (fss) attended the laboratory in order to investigate the circumstances involved in this complaint.The fss noted that the laboratory is "quite certain that a tech placed (b)(4) alcohol in bottle 5 and (b)(6) alcohol into bottle 4 which caused the subsequent water introduction into the xylene and ultimately compromised the tissue processing".The fss offered to provide user training, which was declined by the laboratory.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn rd.; mount waverley; victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley; victoria 3149 ; 92117535
• MDR Report Key: 4954258
• MDR Text Key: 23392322
• Report Number: 8020030-2015-00068
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1