BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 4527560 · Received February 13, 2015

    Report

    Report Number
    9611109-2015-00017
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 14, 2015
    Report Date
    March 8, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    Z-0956/0965-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFO WAS NOT PROVIDED. SORIN GROUP (B)(4) MFRS THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE DURING A PREVENTATIVE MAINTENANCE BY THE SGU FIELD SERVICE REP. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    RECALL: THERE HAVE BEEN TWO FIELD ACTIONS FOR THIS ISSUE. THE Z-NUMBERS ARE Z-0956/0965-2011 AND Z-1149/1158-2012. LIVANOVA (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCED THE REPORTED ISSUE AND REPLACED THE FAULTY LCD TOUCH SCREEN. THE UNIT WAS TESTED WITHOUT ISSUE AND THE SOFTWARE WAS UPGRADED. PREVENTATIVE MAINTENANCE AND A FUNCTIONAL VERIFICATION WERE PERFORMED AND THE UNIT WAS RETURNED TO SERVICE. THE REPLACED TOUCH SCREEN WAS RETURNED TO SORIN GROUP USA FOR FURTHER INVESTIGATION, WHERE A PHOTOGRAPH OF THE KAPTON-TAIL DATE-CODE WAS TAKEN. THE PHOTO WAS PROVIDED TO LIVANOVA (B)(4) FOR REVIEW. ANALYSIS OF THE PHOTOGRAPH BY LIVANOVA (B)(4) CONFIRMED AGING AND WEAR TO BE THE MOST LIKELY ROOT CAUSE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA (B)(4) INITIATED A ROOT CAUSE INVESTIGATION ((B)(4)) FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE DURING A PREVENTATIVE MAINTENANCE BY THE SGU FIELD SERVICE REP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107092 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 NA