BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN HEATER-COOLER SYSTEM 3T

    MDR report key: 5860240 · Received August 9, 2016

    Report

    Report Number
    9611109-2016-00542
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 11, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR CODE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE. TROUBLESHOOTING TRACED THE ERROR TO THE DISTRIBUTION BOARD, WHICH REQUIRED REPLACEMENT. THE SERVICE REPRESENTATIVE WAS ABLE TO IDENTIFY THE PROBABLE ROOT CAUSE TO BE USAGE OF A CHEMICAL CALLED PEROXY II FBC ANTIBACTERIAL FOAMING BATH AND SURFACE CLEANER RATHER THAN REGULAR CLOROX, AS INDICATED IN THE OPERATORS MANUAL. THE FOAMING OF THE PEROXY II FBC CAUSED DAMAGE TO THE 3T HEATER COOLER AND THE DISTRIBUTION BOARD. THE CUSTOMER WAS NOTIFIED TO USE ONLY CLOROX OR MINNCARE FOR THE DISINFECTION PROCEDURE AS INDICATED IN THE OPERATORS MANUAL. THE DISTRIBUTION BOARD WAS REPLACED, FOLLOWED BY PREVENTIVE MAINTENANCE AND A TECHNICAL SAFETY INSPECTION. NO FURTHER ISSUES WERE FOUND AND THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR CODE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509527 SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1