BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT HEATER-COOLER SYSTEM 1T

    MDR report key: 3628003 · Received February 7, 2014

    Report

    Report Number
    1718850-2014-00009
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    October 18, 2011
    Report Date
    January 10, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER, WEIGHT AND AGE WERE NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT HEATER-COOLER SYSTEM 1T. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IT IS SIMILAR TO THE STOCKERT HEATER-COOLER SYSTEM 3T WHICH IS DISTRIBUTED IN THE UNITED STATES. THE 510K FOR THE STOCKERT HEATER-COOLER SYSTEM 3T IS K052601. THE INCIDENT OCCURRED (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE USAGE CONDITIONS OF THE DEVICE. 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 THE PATIENT EXPERIENCED MULTIPLE 3RD DEGREE BURNS WHILE THE HEATER-COOLER SYSTEM 1T WAS BEING USED AS THE HEAT SOURCE FOR A HEATING BLANKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80571 STOCKERT HEATER-COOLER SYSTEM 1T CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER DWC SORIN GROUP DEUTSCHLAND 16-02-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP