BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOCKERT 3T HEATER-COOLER SYSTEM

    MDR report key: 3736372 · Received April 3, 2014

    Report

    Report Number
    1718850-2014-00090
    Event Type
    Other
    Date Received
    April 3, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K052601
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE 3T HEATER-COOLER SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4)RECEIVED A REPORT THAT THE 3T HEATER-COOLER SHUT OFF SEVERAL TIMES DURING A PROCEDURE. A SORIN GROUP FIELD SERVICE TECH REPLACED THE 3TK'S MAINS POWER SWITCH AND THE EQUIPMENT WAS TESTED. ALL FUNCTIONS WORKED PROPERLY AND THE 3T WAS RETURNED TO SERVICE. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE 3T HEATER-COLLER SHUT OFF SEVERAL TIMES DURING A PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203073 TOCKERT 3T HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 16-02-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1