MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP6025; TISSUE PROCESSOR

Model Number 14049543267

Device Problem Human Factors Issue (2948)

Patient Problem Tissue Damage (2104)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

The investigation revealed the following: during the first process step the instrument measured a too low concentration of bottle s1 (ethanol system bottle) with 52%.The instrument screen showed the message that the threshold value for replacing an alcohol was attained.The customer confirmed to replace the alcohol in the next program sequence, and to place an empty replacement bottle in the pull-out at station d4.Then the instrument pumped the used ethanol from bottle s1 into rtu bottle d4.Now the instrument screen showed the message to remove the replacement bottle d4 with the used ethanol and to place a new replacement bottle that is filled with fresh, absolute alcohol (100%) into the pull-out drawer, and to confirm with "yes" after this step was done.The customer didn't replace the bottle d4, but filled then rtu bottle d4 with 100% ethanol.Due to the fact that the rtu bottle d4 was not completely cleaned and empty from the too low concentration of 52% as requested, the concentration was also too low with 93% in rtu (ready to use) bottle d4.This incident was presumably user related, because the user disregarded the informational message on the instrument screen to replace the used ethanol with absolute ethanol.The customer accepted the message by confirming the too low concentration of 93% used ethanol in rtu (ready to use) bottle d4.Then the customer took the already spoiled ethanol from rtu bottle d4 and transferred it into bottle s6 (system bottle) and set the bottle s6 as full.The result was also a too low concentration in bottle s6 with 93%.Due to the fact that now all absolute alcohols were of insufficient quality, especially final alcohol step s6, suboptimal processing is to be expected.This led, in this case, to undiagnosed tissues and a required rebiopsy.A customer facing letter will be sent to the customer with a recommendation in the future of how to properly care for the tissues and reagents during the processing with the tissue processor.

Event Description

On january 11, 2017, the customer reported suboptimal tissue after processing on their leica asp6025.As a result, some specimens could not be diagnosed and one patient is confirmed to require rebiopsy.

• Brand Name: LEICA ASP6025
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 9622414334
• MDR Report Key: 6313569
• MDR Text Key: 66862898
• Report Number: 8010478-2017-00002
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other