BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT HEATER-COOLER SYSTEM 3T

    MDR report key: 3955672 · Received July 18, 2014

    Report

    Report Number
    1718850-2014-00228
    Event Type
    Other
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT SUFFICIENTLY RESULTING IN A PROLONGATION OF BYPASS. THERE WAS NO REPORT OF PATIENT 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 RECEIVED A REPORT THAT THE PATIENT CIRCUIT OF THE 3T HEATER-COOLER DID NOT WARM SUFFICIENTLY RESULTING IN A PROLONGATION OF BYPASS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423142 STOCKERT HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1