BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK GENIE(R) ADVANCED STAINER

    MDR report key: 8021854 · Received October 30, 2018

    Report

    Report Number
    2083544-2018-00006
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 30, 2018
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAKURA INVESTIGATION IDENTIFIED THAT THE FIRE WAS CAUSED BY AN ELECTRICAL SHORT OF THE CONNECTORS OF THE STATION 12 PHOTO SENSOR AND ITS MATING STATION SENSOR CABLE CONNECTOR. THERE WAS NO SPREAD OF FIRE OUTSIDE OF THE SHORTED CONNECTORS. FURTHER INVESTIGATION REVEALED THAT THE FIRE WAS CAUSED BY DISCONNECTION OF THE W1 DRAIN LINE FROM THE ONE-TOUCH FITTING THAT CONNECTS THE DRAIN LINES FROM THE STATION UNIT TO THE STATION TAIL. REAGENT LEAKED ONTO THE STATION UNIT AND INTO THE CONNECTORS. REAGENT BEING ELECTRICALLY CONDUCTIVE, CREATED A CONDUCTIVE LAYER BETWEEN DC24V AND GROUND (LAYER SHORT). AS A RESULT, DIELECTRIC BREAKDOWN OF THE CONNECTORS OCCURRED, MADE THE INSULATOR AND CONNECTOR MATERIAL ELECTRICALLY CONDUCTIVE. MORE CURRENT THEN CONTINUED TO FLOW, OVERHEATED THE CONNECTORS WHICH LEAD TO THE FIRE. THE CAUSE FOR W1 DISCONNECTING FROM THE ONE-TOUCH FITTING HAS BEEN DETERMINED TO BE SERVICE ACTIVITY FOR STATIONS NOT DRAINING ON (B)(6) 2018. WHILE FSE (FIELD SERVICE ENGINEER) WAS AT SITE TROUBLESHOOTING THE STATIONS NOT DRAINING, IT WAS DISCOVERED THAT THE W1/W2 LINES GOING INTO THE DRAIN PAN WERE PINCHED DUE TO SALT BUILD UP. CURRENT RESOLUTION IS TO DISCONNECT THE W1/W2 LINES AND CUT THE TUBING BEFORE THE PINCH. DURING THE COURSE OF DISCONNECTING THE W1/W2 LINES AN EXCESSIVE LOAD WAS APPLIED ONTO THE TUBING, DAMAGED ITS HOLD MECHANISM OF THE FITTING LEADING TO DISCONNECTION OF THE W1 DRAIN LINE. IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS, THE ONE-TOUCH FITTING HAS THE TENSILE STRENGTH OF 1 MPA MAX. AND PULL-OFF STRENGTH OF 8 N. THIS IS CONSIDERED ADEQUATE FOR THIS TYPE OF APPLICATION. BASED ON THIS, IT IS CONCLUDED THAT THERE WAS NO DEVICE MALFUNCTION OR DESIGN DEFICIENCY. THE DEVICE IS SAFE TO USE.

    Description of Event or Problem · 1

    SAKURA FINETEK USA, INC., RECEIVED A COMPLAINT ON 10/2/2018 IN WHICH CUSTOMER STATED THAT THERE WAS AN ERROR MESSAGE ABOUT STATION 12, AND HE SAW A FLAME INSIDE THE UNIT COMING OUT FROM BACK OF THE STATION 12. HE WAS ABLE TO BLOW THEM OUT WITHOUT USING A FIRE EXTINGUISHER. THERE WAS NO DAMAGE TO THE PATIENT SAMPLES, OR INJURY TO THE USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861229 TISSUE-TEK GENIE(R) ADVANCED STAINER GENIE KPA SAKURA FINETEK USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other