BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPENSERS, PARAFFIN

    MDR report key: 18921316 · Received March 18, 2024

    Report

    Report Number
    8010478-2024-00006
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    December 2, 2023
    Report Date
    March 18, 2024
    Manufacturer
    LEICA MICROSYSTEMS LTD. SHANGHAI
    Product Code
    IDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11.03.2024 THE RA/QA DEPARTMENT WAS PROVIDED WITH THE FOLLOWING INVESTIGATION RESULTS: THE ARCADIA H SN (B)(6) WAS MANUFACTURED IN MAI 2017. ON MARCH 23RD, 2021, A REPAIR OF THE INSTRUMENT WAS CARRIED OUT WHERE THE PELTIER ELEMENT AND THE PARAFFIN TANK WERE REPLACED AT THE CUSTOMER SITE. FOLLOWING THE REPAIR, THE INSTRUMENT WAS RETURNED TO REGULAR USE. FURTHER INVESTIGATION REVEALED THAT THE FIELD SERVICE ENGINEER WHO CARRIED OUT THE REPAIR DID NOT ALLOW FOR SUFFICIENT TIME FOR THE SEALANT OF THE PARAFFIN TANK TO PROPERLY CURE. THIS RESULTED IN INCOMPLETE SEALING OF THE PARAFFIN TANK. DURING THE REGULAR OPERATION OF THE INSTRUMENT, WHEN FILLING THE TANK WITH PARAFFIN TO A LEVEL ABOVE THE INDICATED MAXIMUM LINE, THIS LED TO SEEPAGE OF PARAFFIN INTO THE INSTRUMENT. THE PARAFFIN SOAKED INTO THE INSULATION COTTON. TESTING SHOWED THAT PARAFFIN-SOAKED INSULATION COTTON BECOMES FLAMMABLE. DUE TO ITS INCREASED WEIGHT, THE PARAFFIN-SOAKED INSULATION COTTON FELL ONTO THE MOTHER BOARD AND/OR THE AC POWER TERMINAL WHERE IT IGNITED. THE PRECISE POINT OF IGNITION COULD NOT BE DETERMINED. CURRENTLY THE SOURCE OF IGNITION REMAINS UNDER INVESTIGATION. ONCE NEW INFORMATION HAS BEEN OBTAINED AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, LEICA BIOSYSTEMS WAS CONTACTED BY THE CUSTOMER AND PROVIDED THE FOLLOWING INFORMATION: ON (B)(6) 2023 THE INSTRUMENT CAUGHT FIRE DURING USE. DURING THE INITIAL CONTACT WITH THE CUSTOMER LEICA BIOSYSTEMS WAS INFORMED THAT NO TISSUE HAD BEEN NEGATIVELY AFFECTED BY THIS INCIDENT AND THAT NEITHER THE CUSTOMER NOR A THIRD PARTY WERE NEGATIVELY IMPACTED BY THIS EVENT. THE FIRE WAS CONTAINED WITHIN THE INSTRUMENT AND DID NOT SPREAD. DURING THE INITIAL ON-SITE INVESTIGATION OF THE INSTRUMENT THE CUSTOMER INFORMED THE LEICA BIOSYSTEMS FIELD SERVICE ENGINEER, THAT DURING THE INCIDENT THE PARAFFIN IN THE TANK OF THE INSTRUMENT HAD BEEN OBSERVED TO REACH BOILING POINT TEMPERATURES. IT WAS FOUND UPON REMOVAL OF THE REAR COVER PLATE OF THE INSTRUMENT, THAT THE INSULATION COTTON AT THE BOTTOM OF THE PARAFFIN TANK HAD BEEN BURNED. THE EXAMINATION OF THE PARAFFIN TANK HEATING PLATE, INCLUDING A FUNCTIONAL ASSESSMENT AND MEASUREMENT OF THE ELECTRICAL RESISTANCE VALUES OF THE HEATING PLATE, YIELDED NO ABNORMALITIES. BECAUSE NO APPARENT MALFUNCTION COULD BE FOUND DURING THE INITIAL INVESTIGATION, THE INSTRUMENT WAS RETURNED TO THE LEICA BIOSYSTEMS WORKSHOP FOR FURTHER TESTING AND AN IN-DEPTH INVESTIGATION. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192654 DISPENSERS, PARAFFIN IDW HISTOCORE ARCADIA H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown