BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT HEATING-COOLER SYSTEM 3T

    MDR report key: 2974243 · Received February 14, 2013

    Report

    Report Number
    1718850-2013-00018
    Event Type
    Other
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE STOCKERT HEATER-COOLER SYS 3T. THE INCIDENT OCCURRED IN (B)(6). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PT SIDE OF THE 3T HEATER/COOLER WOULD NOT WARM ABOVE 11 DEGREES DURING A PROCEDURE. A BACK-UP HEATER/COOLER WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY. A SORIN GROUP FIELD SVC REP WAS DISPATCHED TO INVESTIGATE. WHILE AT THE FACILITY THE FIELD SVC REP WAS ABLE TO REPRODUCE THE ISSUE AND FOUND THAT THE VOLTAGE TO THE HEATER ELEMENT WAS OUT OF SPECIFICATION. THE AC MAINS BOARD WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT THE ISSUE WAS RESOLVED. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE PT SIDE OF THE 3T HEATER/COOLER WOULD NOT WARM ABOVE 11 DEGREES DURING A PROCEDURE. A BACK-UP HEATER/COOLER WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66165 STOCKERT HEATING-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1