BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3012446 · Received March 14, 2013

    Report

    Report Number
    8020030-2013-00012
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 13, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AT 17:24PM AND 17:26PM BOTTLE 3 (ETHANOL) AND 11 (TPO) WERE REMOVED FROM THE INSTRUMENT FOR LESS THAN 5 SECONDS, WHICH IS INSUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF REAGENTS; AND THE CORRESPONDING REAGENT STATION WAS RESET. THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT ETHANOL AND TPO CONCENTRATION WAS TO BE SET TO 100%. THE PROPERTIES OF THE REAGENT IN BOTTLE 3 AND 11 PRIOR TO THIS USER ACTION WERE ETHANOL CONCENTRATION = 50.4%, AND TPO CONCENTRATION = 67.3%, BECAUSE THE BOTTLES HAD NOT BEEN PHYSICALLY REPLACED. RE-SETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED. THE REAGENT IN BOTTLE 11-14 INCLUSIVE INCLUDING THE WAX FROM WAX BATH 1 WERE REPLACED AND THE CORRESPONDING REAGENT STATION RESET ON (B)(6) 2012, AND THE QUALITY OF TISSUE PROCESSING HAD IMPROVED. HOWEVER, THE WAX IN WAX BATH 3 AND 4 WERE NOT REPLACED. CONTINUED USE OF THE INSTRUMENT WITHOUT REPLACING ALL REAGENTS AND WAX FROM THE WAX BATH, WOULD HAVE RESULTED IN CONTAMINATION OF REAGENTS AND WAXES USED FOR SUBSEQUENT PROTOCOLS, WITH A CONSEQUENT ADVERSE IMPACT ON THE QUALITY OF TISSUE PROCESSING. BY (B)(6) 2013 WAX FROM WAX BATH 3 AND 4 WERE HEAVILY CONTAMINATED AND CAUSED WATER TO ENTER DURING TISSUE PROCESSING, ULTIMATELY RESULTING IN THE SUB-OPTIMAL TISSUE PROCESSING COMPLETED ON (B)(6) 2013. THE COMPLAINANT REPORTED ISSUES WITH MANUAL REAGENT REPLACEMENT PROCESS TO THE LEICA SERVICE REPRESENTATIVE ON (B)(6) 2013. THE ROOT CAUSE FOR THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A FAILURE BY THE USER TO COMPLETE THE MANUAL REAGENT REPLACEMENT PROCESS IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS II USER MANUAL.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL TISSUE PROCESSING USING PELORIS II TISSUE PROCESSOR. THE COMPLAINT DID NOT ADVISE THE SPECIFIC DATE(S) FOR THE PROCESSING RUN(S) FROM WHICH SUB-OPTIMAL PROCESSING WAS IDENTIFIED, BUT ADVISED ONLY THAT PROCESSING QUALITY HAD DECLINED. THE TISSUE WAS DESCRIBED BY THE COMPLAINANT AS "SHRUNKEN AND DRY". ON (B)(6) 2013, LEICA MICROSYSTEMS RECEIVED INFORMATION FROM THE ORGANIZATION REGARDING THE FINAL STATUS OF TISSUE SAMPLES PROCESSED IN THE "ASP2002" PROTOCOL FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. THE INFORMATION RECEIVED STATED THAT RE-BIOPSY OF 13 OF THESE PATIENTS HAD BEEN CONDUCTED AS A CONSEQUENCE. (REFER TO MFR. REPORT# 8020030-2013-00013, 8020030-2013-00014, 8020030-2013-00015, 8020030-2013-00016, 8020030-2013-00017, 8020030-2013-00018, 8020030-2013-00019, 8020030-2013-00020, 8020030-2013-00021, 8020030-2013-00022, 8020030-2013-00023, 8020030-2013-00024 AND 8020030-2013-00025 FOR SPECIFIC DETAILS OF THE PATIENT INVOLVED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108167 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention