BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT HEATER-COOLER SYS 3T

    MDR report key: 3982651 · Received July 25, 2014

    Report

    Report Number
    1718850-2014-00237
    Event Type
    Other
    Date Received
    July 25, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 27, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYS 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(6). SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE 3T HEATER-COOLER POWERED OFF UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY. 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)(6) RECEIVED A REPORT THAT THE 3T HEATER-COOLER POWERED OFF UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436622 STOCKERT HEATER-COOLER SYS 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP