BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 2844952 · Received October 24, 2012

    Report

    Report Number
    1718850-2012-01026
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K955038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURE THE S3 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO INVESTIGATE. WHILE AT THE FACILITY THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE. A REVIEW OF THE MACHINE'S INTERNAL MEMORY CONFIRMED REDUCED FLOW AND PRESSURE AT THE TIME OF THE INCIDENT. INSPECTION OF THE DEVICE FOUND THAT THE MOTOR WAS NOT MOVING FREELY. THE MOTOR WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT THE ISSUE WAS RESOLVED. THE HOSPITAL HAS RETAINED THE MOTOR THAT WAS REPLACED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT THE PUMP FROZE UP DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMINISTERED CARDIAC MASSAGE UNTIL THE SYSTEM COULD BE CHANGED OUT FOR A BACKUP. SORIN REQUESTED INFORMATION ON PATIENT STATUS BUT THE FINAL PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-65-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention