BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA HE 600 SYSTEM

    MDR report key: 11846467 · Received May 18, 2021

    Report

    Report Number
    2028492-2021-00005
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 24, 2022
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    KPA
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    2028492-06-01-2022-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION, THE CUSTOMER ISSUE WAS RESOLVED BY REPLACEMENT OF THE STAINER MODULE BY FIELD SERVICE ENGINEER, AT THE CUSTOMER SITE. THE INSTRUMENT WAS RETURNED TO ROUTINE OPERATION. THE AFFECTED STAINER MODULE WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THERE WAS SUFFICIENT EVIDENCE TO SUBSTANTIATE THE ALLEGATION OF SHORTING WITHIN THE INSTRUMENT. VISUAL AND SURFACE INSPECTION SHOWED NO OBVIOUS AREA FOR LEAKS WITHIN THE TUBING AFTER THE STAINER HAD BEEN REMOVED FROM THE INSTRUMENT. THE SHORTING WAS CONTAINED WITHIN THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 0

    ROCHE HAS CONFIRMED COMPLAINTS REGARDING FLUID LEAKS WITHIN THE MIDDLE STAINER MODULE OF THE VENTANA HE 600 THAT LIKELY RESULTED IN ELECTRICAL SHORTS AT THE PLATE HEATER CONNECTIONS THAT THEN ESCALATED INTO FIRES. IN THE CASES, THE FIRE ORIGINATED FROM THE MIDDLE STAINER MODULES AT THE BACKSIDE OF THE CONNECTORS FOR THE PLATE HEATERS. A THIRD PARTY FIRE ANALYSIS INVESTIGATION WAS CONDUCTED FOR THE CASES AND A CAPA HAS BEEN INITIATED. BECAUSE THE FIRE AND ANY ASSOCIATED SMOKE COULD EXTEND BEYOND THE INSTRUMENT, THERE IS A RISK OF INJURY, POTENTIALLY SERIOUS, FROM SMOKE INHALATION AND/OR DIRECT CONTACT WITH THE FIRE ITSELF. ROUTINE FIRE/SMOKE SAFETY AND EVACUATION PROCEDURES MITIGATE THE RISK OF INJURY. ADDITIONALLY, GIVEN THE ABILITY TO RETEST THE PATIENT SAMPLE, THE PROBABILITY THAT THIS FAILURE MODE WOULD RESULT IN ADVERSE HEALTH CONSEQUENCES FOR PATIENTS IS ESTIMATED AS VERY LOW. NO INJURIES HAVE BEEN REPORTED TO DATE. CONSIGNEES HAVE BEEN NOTIFIED TO NOT LEAVE THE INSTRUMENT UNATTENDED WHEN THE POWER IS ON. CONSIGNEES WERE ALSO INSTRUCTED NOT TO PLACE THE SYSTEM IN STANDBY MODE OVERNIGHT WHEN UNATTENDED UNTIL FURTHER MITIGATION ACTIONS HAVE BEEN IMPLEMENTED AND TO PLEASE TURN OFF THE POWER OF THE INSTRUMENT WHEN IT IS UNATTENDED. A STAINER TEMPERATURE MONITORING UPDATE WILL BE IMPLEMENTED AND PLATE HEATER CONNECTORS WILL BE COATED WITH LIQUID ELECTRICAL TAPE (LET). THESE ACTIONS MITIGATE THE RISK BY MONITORING THE TEMPERATURE AND BY PROTECTING THE SOURCES FROM LEAKS AND SUBSEQUENTLY A SHORT CIRCUIT, WHICH WOULD PREVENT THE POSSIBILITY OF HEAT GENERATION. CHANGED DEVICE CODE FROM CIRCUIT FAILURE TO LEAK/SPLASH.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BACK FOR EVALUATION. AN INVESTIGATION TO EVALUATE THE CUSTOMER ISSUE IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(6) REPORTED THAT THEIR HE 600 SYSTEM EXPERIENCED AN INSTRUMENT LEAK ALONG ACCOMPANIED WITH A TUB OVERFLOW ALARM; MOST LIKELY RESULTING IN AN ELECTRIC SHORT. THE INSTRUMENT MADE A SOUND AND A LOCALIZED SMOKE WAS NOTICED. THE SMOKE WAS CONTAINED WITHIN THE INSTRUMENT AND THE SITUATION DID NOT TRIGGER ANY SMOKE ALARM OR LABORATORY EVACUATIONS. NO ALLEGED HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742284 VENTANA HE 600 SYSTEM SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown