BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 2730696 · Received August 29, 2012

    Report

    Report Number
    1718850-2012-00949
    Event Type
    Other
    Date Received
    August 29, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K060053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 TOUGH SCREEN, WHICH IS A COMPONENT OF THE S5 DOUBLE HEAD PUMP. THE 510(K) NUMBER OF THE S5 DOUBLE HEAD PUMP IS K060053. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHILE SORIN GROUP SERVICE REPRESENTATIVE WAS AT A CUSTOMER SITE TO PERFORM A PREVENTATIVE MAINTENANCE, THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP RESPONDED INCORRECTLY TO TOUCH. THE TOUCH SCREEN WAS REPLACED BY THE SERVICE REPRESENTATIVE. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT WHILE A SORIN GROUP SERVICE REPRESENTATIVE WAS AT A CUSTOMER SITE TO PERFORM A PREVENTATIVE MAINTENANCE, THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP RESPONDED INCORRECTLY TO TOUCH. THE TOUCH SCREEN WAS REPLACED BY THE SERVICE REPRESENTATIVE. THERE WAS NOT PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1