BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSOR MODULE FOR S3 DPC

    MDR report key: 3853743 · Received May 30, 2014

    Report

    Report Number
    1718850-2014-00156
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 2, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE S3 ROLLER PUMP STOPPED DURING A PROCEDURE DUE TO AN ERROR DISPLAYED IN THE PRESSURE MODULE. THE SERVICE REPRESENTATIVE COULD NOT REPRODUCE THE ISSUE. ALL SETTING, CONFIGURATIONS AND MODULES WERE CORRECT. THE PUMP AND CONTROL WERE TESTED WITHOUT ANY MALFUNCTIONS. THE SENSOR MODULE WAS REPLACED AS A PRECAUTION. THERE HAS BEEN NO TREND IDENTIFIED FOR THIS TYPE OF ISSUE. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF PT INJURY. SORIN GROUP (B)(4) MFR THE S3 ROLLER PUMP SYSTEM AND SENSOR MODULE FOR S3 DPC. 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 S3 ROLLER PUMP STOPPED 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)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP STOPPED DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319919 SENSOR MODULE FOR S3 DPC CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 22-10-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR