BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 4922705 · Received July 14, 2015

    Report

    Report Number
    9611109-2015-00255
    Event Type
    Other
    Date Received
    July 14, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWC
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE 510K# PROVIDED IN THE INITIAL MEDWATCH REPORT WAS INCORRECT. THE CORRECT 510K# IS K052601. SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THAT THE HEATER-COOLER WAS DISPLAYING AN ERROR DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT. NOTHING WAS RETURNED FOR INVESTIGATION. THE UNIT WAS EVALUATED BY THE HOSPITAL BIOMEDICAL ENGINEER AND THE REPORTED ERROR COULD BE SOLVED BY RE-CALIBRATION OF THE TEMPERATURE SENSORS. THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES WITH THIS UNIT. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY CONCESSIONS, DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATING TO THIS TYPE OF ISSUE. EVALUATION PERFORMED BY USER FACILITY.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE HEATER-COOLER WAS DISPLAYING AN ERROR DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457839 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND GMBH 16-02-85U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA