BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE PROCESSOR SYSTEM

    MDR report key: 8224339 · Received January 7, 2019

    Report

    Report Number
    3022521-2018-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIO-RAD TECHNICAL SUPPORT WAS CONTACTED BY (B)(6) ON (B)(6) 2018, TO REPORT THAT THE POWER STRIP CONNECTED TO THE EVOLIS MICROPLATE SYSTEM SPARKED WHEN THE POWER WAS TURNED ON. A BIO-RAD LABORATORIES FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE INCIDENT. THE FSE DISCOVERED THAT A NYLON RETAINING NUT THAT SECURES THE LIQUID WASTE TUBING INTO THE LIQUID WASTE CONTAINER HAD COME OFF WHICH ALLOWED THE LIQUID WASTE TUBING TO COME OUT OF THE LIQUID WASTE CONTAINER. THE LIQUID WASTE WAS PUMPED INTO THE SYSTEM CABINET WHERE THE POWER STRIP AND UNINTERRUPTIBLE POWER SUPPLY (UPS) ARE LOCATED. SOME OF THE LIQUID WASTE WAS ABLE TO GET ON/IN THE POWER STRIP AND WHEN POWER WAS APPLIED THIS CAUSED THE POWER STRIP TO SPARK. ADDITIONALLY, THE SPARK LEFT A SCORCH MARK ON THE POWER STRIP. THE FSE REPLACED THE POWER STRIP, UPS, AND LIQUID WASTE CONTAINER (WHICH INCLUDES THE NYLON RETAINING NUT). ALSO AS PART OF THE INVESTIGATION THE FSE PERFORMED PERFORMANCE VERIFICATION TESTING TO ENSURE THE SYSTEM MET ALL MANUFACTURER SPECIFICATIONS. ALL TESTS MET MANUFACTURER SPECIFICATION AND THE SYSTEM WAS RETURN TO FULL OPERATION PRIOR TO RELEASING THE SYSTEM TO THE CUSTOMER. BIO-RAD LABORATORIES IS REPORTING THIS ISSUE AS AN MDR DUE TO THE FOLLOWING RISKS EVEN THOUGH THERE WAS NO HARM TO PATIENT OR END USER DURING THIS INCIDENT: SINCE THE POWER STRIP SPARKED IT WAS A POTENTIAL FIRE HAZARD, AND THERE WAS INCREASED RISK TO END USER FOR EXPOSURE TO BIO-HAZARDOUS WASTE SINCE THE LIQUID WASTE WAS NOT BEING PUMPED INTO THE PROPER CONTAINER. BIO-RAD LABORATORIES HAS REVISED THE EVOLIS PREVENTIVE MAINTENANCE REPORT TO INCLUDE INSPECTION OF THE NYLON RETENTION NUT FOR THE LIQUID WASTE TUBING TO REDUCE THE RISK OF RECURRENCE OF THIS INCIDENT. THE CHANGE IS LISTED UNDER THE SIMI-ANNUAL PM KIT PARTS SECTION SPECIFIC TO THE EXTERNAL LIQUID WASTE TUBING, AND STATES: "ALSO VERIFY THE WASTE BOTTLE TUBING KEEPER NUT IS MOUNTED PROPERLY AND IN GOOD CONDITION. REPLACE AS NEEDED 14MM PLASTIC NUT OR ENTIRE BOTTLE PN 89715." EVOLIS PREVENTIVE MAINTENANCE REPORT. FIELD SERVICE PERSONNEL WILL BE NOTIFIED OF THE CHANGE TO THE PREVENTIVE MAINTENANCE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15832 EVOLIS MICROPLATE PROCESSOR SYSTEM EVOLIS JJE BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1