BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT HEATER-COOLER SYSTEM 3T

    MDR report key: 4170576 · Received September 30, 2014

    Report

    Report Number
    1718850-2014-00355
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE REPORTED ISSUE WAS CONFIRMED AND THE TECHNICIAN REPLACED SEVERAL BOARDS BUT WAS UNABLE TO RESOLVE THE MALFUNCTION IN THE FIELD. THE DEVICE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR ADDITIONAL INVESTIGATE. THE OEM FOUND THAT THE ISSUE WAS CAUSED BY THE POWER SUPPLY, WHICH WAS NOT COMPATIBLE WITH THE POWER SOURCE IN (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TOT HE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT HEATER-COOLER DISPLAYED MULTIPLE ERROR MESSAGES AND DID NOT FUNCTION DURING SET UP, AFTER A NEW MAINS AC BOARD WAS INSTALLED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608954 STOCKERT HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA