BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT 3T HEATER-COOLER SYSTEM

    MDR report key: 3883990 · Received June 12, 2014

    Report

    Report Number
    1718850-2014-00205
    Event Type
    Other
    Date Received
    June 12, 2014
    Date of Event
    March 25, 2014
    Report Date
    June 12, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFO WAS NOT PROVIDED. 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 DEUTSCHLAND. SORIN GROUP REC'D A REPORT THAT THE 3T HEATER-COOLER SHUT OFF DURING A PROCEDURE. A SORIN GROUP FIELD SERVICE TECHNICIAN WAS SENT TO THE FACILITY TO INVESTIGATE. THERE WAS NO REPORT OF PATIENT 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 REC'D A REPORT THAT THE 3T HEATER-COOLER SHUT OFF DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348223 STOCKERT 3T HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP